BETHLEHEM, Pa. & PLYMOUTH, Minn.--(BUSINESS WIRE)--January 29, 2009--Invatec, a comprehensive innovator of interventional products, today announced that it has entered a worldwide distribution agreement with Lumen Biomedical, Inc. to distribute the FiberNet ® Embolic Protection System (EPS). The FiberNet EPS, which received FDA clearance in November, is indicated for the treatment of patients receiving endovascular intervention for carotid artery disease. The product has also received CE Mark approval for use during carotid and saphenous vein graft (SVG) procedures.
Full article >> http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&newsId=20090129005116&newsLang=en
Saturday, January 31, 2009
Concentric Medical Expands Product Offering in Neuro Access
MOUNTAIN VIEW, Calif., Jan. 29 /PRNewswire/ -- Concentric Medical, Inc., the global leader in devices for clot removal in ischemic stroke patients, today announced the release in the U.S. of two new lengths of the Outreach(TM) Distal Access Catheter for use in neurovascular interventions. The Outreach Distal Access Catheter provides neurointerventionalists additional access and support options during minimally invasive procedures in the brain.
Concentric Medical released its first Outreach Distal Access Catheter in the U.S. and Europe in October 2008. The catheter, which was specifically designed to provide support and access in Merci Retrieval procedures, has been well received by the neurointerventional community. These two new lengths of the Outreach Distal Access Catheter are in direct response to physician feedback that the catheter is a valuable tool for other interventions in the brain.
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Concentric Medical released its first Outreach Distal Access Catheter in the U.S. and Europe in October 2008. The catheter, which was specifically designed to provide support and access in Merci Retrieval procedures, has been well received by the neurointerventional community. These two new lengths of the Outreach Distal Access Catheter are in direct response to physician feedback that the catheter is a valuable tool for other interventions in the brain.
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Cook Medical unveils the Advance Drug-Eluting Balloon and Other Cutting-Edge Devices at ISET
Event was punctuated by several product introductions and a live case demonstration of percutaneous transluminal angioplasty using a drug-eluting balloon
BLOOMINGTON, Ind., Jan 30, 2009 - (HSMN NewsFeed) - In a live case transmitted from The Heart Center Leipzig/Park Hospital in Leipzig, Germany, a new drug-eluting balloon was used as part of a clinical trial during one of the live case demonstrations at last week’s ISET 2009 International Symposium on Endovascular Therapy. Advance PTX is designed to increase long-term patency in patients with peripheral arterial disease (PAD) and is one of the first PTA balloon catheters to be coated with paclitaxel, an antiproliferative drug that has been used successfully to reduce the risk of arterial restenosis following angioplasty in coronary disease patients.
“Bringing together converging technologies—like devices with pharmaceuticals in the case of the Advance PTX balloon—is a critical step in developing advanced medical devices to improve outcomes in specific patient populations,” said Rob Lyles, vice president and global leader of Cook Medical's peripheral intervention division.Cook also introduced several products from its premier line of diagnostic and peripheral interventional devices at ISET 2009, including its Approach™ CTO microwires. The Approach CTO microwires are the first .014-inch wires designed specifically for crossing chronic total occlusions and extremely tight lesions in the peripheral arteries, including the SFA, popliteal and tibial arteries.
Neurosurgery Journal Issues Supplement Dedicated to CyberKnife Radiosurgery Experience
Supplement Features 15 Peer Reviewed Papers Describing CyberKnife Radiosurgery for Brain and Spine Applications
SUNNYVALE, Calif., Jan. 30 (HSMN NewsFeed) -- Accuray Incorporated (Nasdaq: ARAY ), a global leader in the field of radiosurgery, announced today that Neurosurgery, the official journal of the Congress of Neurological Surgeons, has issued a peer-reviewed supplement dedicated to CyberKnife radiosurgery experience.
The supplement, titled "CyberKnife Stereotactic Robotic Radiosurgery" features 15 papers from seven different countries, focused on brain and spine treatment using the CyberKnife® Robotic Radiosurgery System. All papers were subjected to thorough peer review by the editorial board of Neurosurgery and describe a wide range of CyberKnife treatment experiences. These papers highlight experience with the CyberKnife System from studies as large as 1,075 patients and for follow-up periods up to five years or more.
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SUNNYVALE, Calif., Jan. 30 (HSMN NewsFeed) -- Accuray Incorporated (Nasdaq: ARAY ), a global leader in the field of radiosurgery, announced today that Neurosurgery, the official journal of the Congress of Neurological Surgeons, has issued a peer-reviewed supplement dedicated to CyberKnife radiosurgery experience.
The supplement, titled "CyberKnife Stereotactic Robotic Radiosurgery" features 15 papers from seven different countries, focused on brain and spine treatment using the CyberKnife® Robotic Radiosurgery System. All papers were subjected to thorough peer review by the editorial board of Neurosurgery and describe a wide range of CyberKnife treatment experiences. These papers highlight experience with the CyberKnife System from studies as large as 1,075 patients and for follow-up periods up to five years or more.
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SonoSite Introduces Powerful New Turbo Technology for S Series(TM)
New Color Flow, New Remote Control, New Workflow Integration Capabilities
SonoSite Demonstrating SonoGT at SCCM Congress in Nashville, February 1-3.
BOTHELL, WA- January 30, 2009 - (HSMN NewsFeed) - SonoSite, Inc. (Nasdaq:SONO), the world leader and specialist in hand-carried ultrasound for point-of-care medicine, announced today that its new SonoGT™ Global Target technology is now available on SonoSite’s award-winning, mountable S Series™ ultrasound tools. The new performance platform delivers enhanced color flow sensitivity, wireless connectivity, including a remote control for hands-free system control and workflow integration for multiple point-of-care application markets.
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SonoSite Demonstrating SonoGT at SCCM Congress in Nashville, February 1-3.
BOTHELL, WA- January 30, 2009 - (HSMN NewsFeed) - SonoSite, Inc. (Nasdaq:SONO), the world leader and specialist in hand-carried ultrasound for point-of-care medicine, announced today that its new SonoGT™ Global Target technology is now available on SonoSite’s award-winning, mountable S Series™ ultrasound tools. The new performance platform delivers enhanced color flow sensitivity, wireless connectivity, including a remote control for hands-free system control and workflow integration for multiple point-of-care application markets.
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Friday, January 30, 2009
Polymedco Introduces Point of Care Test for Recurrent Bladder Cancer Detection
BTA stat(R) Test Detects Bladder Tumor Associated Antigen in UrineCORTLANDT MANOR, N.Y., Jan. 29 (HSMN NewsFeed) -- Polymedco, Inc. is pleased to announce the direct availability of the BTA stat(R) test from our sales force -- The BTA stat(R) test is a point of care technology for the early detection of recurrent bladder cancer. This method uses monoclonal antibodies to detect the presence of bladder tumor associated antigen in urine. It is a single-step, rapid immunochromatographic assay for bladder tumor-associated antigen in voided urine. The specificity of the BTA stat(R) test was 93 - 95% in patients with non-genitourinary diseases and cancers and healthy individuals tested as part of a multi-center study. The test has a sensitivity that is considerably higher than voided urine cytology, enabling detection of recurrent early stage and grade cancers that cytology often misses. Requiring three drops of urine, the result is delivered in only five minutes. The appearance of a line in the patient window indicates a positive result. The BTA stat(R) test requires one voided urine sample with no sample preparation. The BTA stat(R) test is CLIA waived and also available for prescription home use.
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Prosurgics Announces Receipt of CE Mark for Its New FreeHand(R) Robotic Camera Holder
CUPERTINO, CA--(HSMN NewsFeed)--Jan 29, 2009 -- Prosurgics, the surgical robotics company, announces receipt of CE certification for its new FreeHand® robotic camera holder. Underwriters Laboratories certified the product on 22nd January, opening the way to customer deliveries of FreeHand throughout Europe and those other countries whose certification or licensing requirements are based on the CE mark.
FreeHand is the first product in Prosurgics' new generation of affordable surgical robotics. Suitable for every laparoscopic procedure, it provides superior visualization and the ability for surgeons to directly control movement of the scope, by means of Prosurgics' patented "surgeon head movement" interface. FreeHand has already collected innovation awards on both sides of the Atlantic, along with growing interest from surgeons, many of whom are increasingly struggling to find reliable assistance. FreeHand is a solution to this need and enables increased throughput and efficiency.
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FreeHand is the first product in Prosurgics' new generation of affordable surgical robotics. Suitable for every laparoscopic procedure, it provides superior visualization and the ability for surgeons to directly control movement of the scope, by means of Prosurgics' patented "surgeon head movement" interface. FreeHand has already collected innovation awards on both sides of the Atlantic, along with growing interest from surgeons, many of whom are increasingly struggling to find reliable assistance. FreeHand is a solution to this need and enables increased throughput and efficiency.
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SurModics and Nexeon MedSystems to Collaborate on Development of Novel Stent System for Renal Artery Disease
Agreement Represents Second Stent Development Collaboration Between SurModics and Nexeon MedSystems
EDEN PRAIRIE, Minn. & CHARLESTON, W. Va., Jan 27, 2009 --(HSMN NewsFeed)-- SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, and Nexeon MedSystems, Inc., a developer of medical devices for the treatment of cardiovascular and peripheral vascular disease, announced today that the companies have signed a licensing agreement to collaborate on development of a novel stent system for the treatment of renal artery disease.
This agreement is in addition to the prior one announced in July 2007 to develop a novel stent system for coronary artery disease, which is now in clinical trials. SurModics is also an equity investor in Nexeon MedSystems.This novel stent system for the renal arteries will incorporate SurModics' proprietary Finale(TM) Prohealing Coating technology and Nexeon's bare metal KODIAK(TM) peripheral stent technology. Terms of the agreement were not disclosed.
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EDEN PRAIRIE, Minn. & CHARLESTON, W. Va., Jan 27, 2009 --(HSMN NewsFeed)-- SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, and Nexeon MedSystems, Inc., a developer of medical devices for the treatment of cardiovascular and peripheral vascular disease, announced today that the companies have signed a licensing agreement to collaborate on development of a novel stent system for the treatment of renal artery disease.
This agreement is in addition to the prior one announced in July 2007 to develop a novel stent system for coronary artery disease, which is now in clinical trials. SurModics is also an equity investor in Nexeon MedSystems.This novel stent system for the renal arteries will incorporate SurModics' proprietary Finale(TM) Prohealing Coating technology and Nexeon's bare metal KODIAK(TM) peripheral stent technology. Terms of the agreement were not disclosed.
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K2M Introduces a Simplified Minimally Invasive Surgical Technique for Dynamic Stabilization of the Spine
Spinal Device Company Plans International Launch of POTOMAC and SERENGETI Spinal Systems
LEESBURG, VA, January 27, 2009 – (HSMN NewsFeed) - K2M, Inc., the spinal device company developing innovative and simplified solutions for the treatment of complex spinal pathologies and procedures, today announced the introduction of a revolutionary minimally invasive approach to dynamic fixation of the spine. The POTOMAC™ Rod System and the SERENGETI™ Minimally Invasive Retractor System have received CE Mark clearance for international distribution to expand the global presence of K2M technologies.
The POTOMAC Rod System, which will be distributed outside the United States, provides a simple and versatile one-piece rod design to enhance the stabilization characteristics of the spine. K2M has secured the exclusive rights to a unique manufacturing process of the material properties of “Nitinol,” a shape memory alloy. The intrinsic elasticity of the rod provides stabilization of the spine, while potentially reducing problems typically associated with traditional fusion materials. Additionally, the simplistic design allows POTOMAC to be implanted using traditional surgical techniques or by using the innovative SERENGETI Minimally Invasive Retractor System.
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LEESBURG, VA, January 27, 2009 – (HSMN NewsFeed) - K2M, Inc., the spinal device company developing innovative and simplified solutions for the treatment of complex spinal pathologies and procedures, today announced the introduction of a revolutionary minimally invasive approach to dynamic fixation of the spine. The POTOMAC™ Rod System and the SERENGETI™ Minimally Invasive Retractor System have received CE Mark clearance for international distribution to expand the global presence of K2M technologies.
The POTOMAC Rod System, which will be distributed outside the United States, provides a simple and versatile one-piece rod design to enhance the stabilization characteristics of the spine. K2M has secured the exclusive rights to a unique manufacturing process of the material properties of “Nitinol,” a shape memory alloy. The intrinsic elasticity of the rod provides stabilization of the spine, while potentially reducing problems typically associated with traditional fusion materials. Additionally, the simplistic design allows POTOMAC to be implanted using traditional surgical techniques or by using the innovative SERENGETI Minimally Invasive Retractor System.
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Cancer Patients in Sweden and Estonia Receive Faster, More Precise Radiation Therapy Treatments
Uppsala University Hospital and Lund University Hospital in Sweden and Tartu University Hospital in Estonia invest in advanced radiotherapy systems from Elekta, a world leader in radiation therapy and radiosurgery treatment solutions.
Stockholm, Sweden January 27, 2009--(HSMN NewsFeed)--Installation of the new Elekta Synergy® systems from Elekta will enable the three university hospitals to begin treating patients with Elekta VMAT (Volumetric Modulated Arc Therapy), a new treatment technology that offers shortened treatment times with the highest degree of precision.
With Elekta Synergy, hospitals in Uppsala and Tartu will for the first time offer patients Image Guided Radiation Therapy (IGRT), which enables hospital personnel to visualize the tumor at the time of treatment, while the hospital in Lund will extend its capacity for this type of targeted treatment.The order from Tartu University Hospital will be the first Elekta linear accelerator in Estonia. Due to significant demand in the region, installation of the new equipment will commence immediately. The hospital also has the radiation treatment planning system, XiO®, from CMS Software. CMS became part of the Elekta Group in 2008.
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Stockholm, Sweden January 27, 2009--(HSMN NewsFeed)--Installation of the new Elekta Synergy® systems from Elekta will enable the three university hospitals to begin treating patients with Elekta VMAT (Volumetric Modulated Arc Therapy), a new treatment technology that offers shortened treatment times with the highest degree of precision.
With Elekta Synergy, hospitals in Uppsala and Tartu will for the first time offer patients Image Guided Radiation Therapy (IGRT), which enables hospital personnel to visualize the tumor at the time of treatment, while the hospital in Lund will extend its capacity for this type of targeted treatment.The order from Tartu University Hospital will be the first Elekta linear accelerator in Estonia. Due to significant demand in the region, installation of the new equipment will commence immediately. The hospital also has the radiation treatment planning system, XiO®, from CMS Software. CMS became part of the Elekta Group in 2008.
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First product from collaboration between RaySearch and TomoTherapy receives FDA clearance
STOCKHOLM, Sweden--(HSMN NewsFeed)--RaySearch Laboratories AB (STO:RAYB) and TomoTherapy Inc. announced today that the new software solution SharePlan(TM) has received 510(k) clearance by the FDA and can now be market launched.
SharePlan™ is an advanced treatment planning solution that enables transfer of treatment plans between TomoTherapy® Hi•Art® systems and conventional linear accelerators. The product uses highly sophisticated algorithms to automatically generate a selection of deliverable high-quality IMRT plans based on an existing Hi•Art® plan. This time-saving concept is an important tool for optimizing patient benefit and throughput at clinics that are introducing a Hi-Art® system into an environment with existing conventional linear accelerators.
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SharePlan™ is an advanced treatment planning solution that enables transfer of treatment plans between TomoTherapy® Hi•Art® systems and conventional linear accelerators. The product uses highly sophisticated algorithms to automatically generate a selection of deliverable high-quality IMRT plans based on an existing Hi•Art® plan. This time-saving concept is an important tool for optimizing patient benefit and throughput at clinics that are introducing a Hi-Art® system into an environment with existing conventional linear accelerators.
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Monday, January 26, 2009
Medtronic Starts 'VITALITY,' a Post-Market Study of the Talent(TM) Abdominal Stent Graft
Innovative Medical Device Extends Possibility of Minimally Invasive Endovascular Repair of Aortic Aneurysms to More PatientsMINNEAPOLIS – Jan. 26, 2009 – (HSMN NewsFeed) - Medtronic, Inc. (NYSE: MDT), today reported the first enrollment in VITALITY1, the company’s post-market clinical study of its Talent Abdominal Stent Graft for the endovascular repair of abdominal aortic aneurysms.
“VITALITY will gather clinically relevant data on the safety and efficacy of the Talent Abdominal Stent Graft in a real-world U.S. patient population,” said vascular surgeon Dr. George Pliagas, who led the team at St. Mary’s Medical Center in Knoxville, Tenn., that performed the first study implant on December 29, 2008.
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“VITALITY will gather clinically relevant data on the safety and efficacy of the Talent Abdominal Stent Graft in a real-world U.S. patient population,” said vascular surgeon Dr. George Pliagas, who led the team at St. Mary’s Medical Center in Knoxville, Tenn., that performed the first study implant on December 29, 2008.
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Varian Medical Systems and BrainLAB to Showcase Novalis Tx(TM) Platform for Non-Invasive Image-Guided Radiosurgery
Powerful Technology for the Non-Invasive Treatment of Cancer on Display at the 45th Annual Society of Thoracic Surgeons (STS) Meeting in San Francisco January 25-27, 2009
PALO ALTO, Calif., Jan. 26 (HSMN NewsFeed) -- A new non-invasive surgical device for eradicating inoperable lung cancer and other conditions is being showcased this week at the 45th Annual Society of Thoracic Surgeons (STS) Meeting in San Francisco. The Novalis Tx(TM) platform from Varian Medical Systems (NYSE: VAR ) and BrainLAB enables doctors to perform image-guided radiosurgery on tumors of the lung, as well as of the brain, spine, liver, and prostate, without making a single incision.
Novalis Tx performs stereotactic body radiotherapy (SBRT), a form of non-invasive radiosurgery that uses precisely-shaped and targeted radiation beams to treat tumors and non-malignant growths from outside the body.
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PALO ALTO, Calif., Jan. 26 (HSMN NewsFeed) -- A new non-invasive surgical device for eradicating inoperable lung cancer and other conditions is being showcased this week at the 45th Annual Society of Thoracic Surgeons (STS) Meeting in San Francisco. The Novalis Tx(TM) platform from Varian Medical Systems (NYSE: VAR ) and BrainLAB enables doctors to perform image-guided radiosurgery on tumors of the lung, as well as of the brain, spine, liver, and prostate, without making a single incision.
Novalis Tx performs stereotactic body radiotherapy (SBRT), a form of non-invasive radiosurgery that uses precisely-shaped and targeted radiation beams to treat tumors and non-malignant growths from outside the body.
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BSD Medical: BSD-2000 Hyperthermia System Installed at Long Beach Memorial Medical Center
SALT LAKE CITY, Jan. 26, 2009 -- (HSMN NewsFeed) -- BSD Medical Corporation (NasdaqGM:BSDM ) today reported that a BSD-2000 hyperthermia system purchased by the Todd Cancer Institute at Long Beach Memorial Medical Center, Department of Radiation Oncology, has been installed for participation in ongoing clinical investigations of the use of deep hyperthermia delivered using the BSD-2000 in combination with radiotherapy for the treatment of patients suffering from locally advanced, persistent, or recurrent deep tumors of the pelvis under an FDA approved protocol. Long Beach memorial provides a multidisciplinary arsenal of cancer treatment options, including hyperthermia, to the Southern California region. ``We are excited to have the BSD-2000 installed at our institution. In addition to providing a complete cancer therapy program for treating superficial tumors, we can now also participate in clinical studies of tumors deep in the body,'' said Dr. Nisar Syed, chief of radiology at Long Beach Memorial Medical Center.
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Pfizer to Acquire Wyeth
NEW YORK & MADISON, N.J.--(HSMN NewsFeed)--Pfizer (NYSE: PFE ) and Wyeth (NYSE: WYE ) today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Wyeth in a cash-and-stock transaction currently valued at $50.19 per share, or a total of approximately $68 billion. The Boards of Directors of both companies have approved the combination.
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Concentric Medical Reaches Important Stroke Milestone
MOUNTAIN VIEW, California, January 26 (HSMN NewsFeed) -- Concentric Medical, Inc., the global leader in devices for clot removal in ischemic stroke patients, today announced that the company's Merci Retrieval System(TM) has been used in over 10,000 patients since its launch in August 2004. The Merci Retrieval System is a catheter-based medical device that advanced stroke centers use to remove blood clots from patients suffering an ischemic stroke.
The Merci Retrieval System has been used by leading stroke institutions around the world. In commenting on this accomplishment, Dr. Marilyn Rymer, Medical Director at Saint Luke's Mid-America Brain and Stroke Institute in Kansas City, MO, said, "This milestone marks a great achievement in the advancement of interventional stroke care both in the U.S. and around the world. At Saint Luke's Hospital in Kansas City, we have used the device in over 300 stroke victims, old and young, with very impressive results. Concentric Medical and the Merci Retrieval System have revolutionized the way we treat stroke."
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The Merci Retrieval System has been used by leading stroke institutions around the world. In commenting on this accomplishment, Dr. Marilyn Rymer, Medical Director at Saint Luke's Mid-America Brain and Stroke Institute in Kansas City, MO, said, "This milestone marks a great achievement in the advancement of interventional stroke care both in the U.S. and around the world. At Saint Luke's Hospital in Kansas City, we have used the device in over 300 stroke victims, old and young, with very impressive results. Concentric Medical and the Merci Retrieval System have revolutionized the way we treat stroke."
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Johnson & Johnson Completes Acquisition of Mentor Corporation
NEW BRUNSWICK, N.J., Jan. 23 (HSMN NewsFeed) -- Johnson & Johnson (NYSE: JNJ ) today announced the completion of its previously announced acquisition of Mentor Corporation (NYSE: MNT ), a leading supplier of medical products for the global aesthetic market. Mentor is expected to operate as a stand-alone business unit reporting through ETHICON, Inc., a Johnson & Johnson company and a leading provider of suture, mesh and other products for a wide range of surgical procedures.
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Cardo Medical Announces the Initial Release of Its Press-Fit Total Hip System
LOS ANGELES, CA--(HSMN NewsFeed)--Jan 22, 2009 -- Cardo Medical (OTC BB:CDOM.OB ), a company engaged in the development of orthopedic medical devices, announces the initial release of its Press-Fit Total Hip system. The Press-Fit Total Hip system incorporates a dual taper design which has a long, proven clinical history with great implant success rates. Cardo Medical's innovations will include instrument enhancements which are designed to significantly improve upon existing offerings. The Press-Fit Total Hip system has already completed a number of successful surgeries with great feedback from surgeon thought leaders on the implant design and instrument innovations. The initial regional release will follow with a rolling commercial release to an expanded surgeon network over the first half of this year. As a complement to the Press-Fit Total Hip system, Cardo Medical is also preparing to release its Bipolar Hip system within the next month.
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Spectranetics Reports on 12-Month CELLO Data
Freedom from Re-Intervention Achieved in 78% of Patients 12 Months Post-Procedure
COLORADO SPRINGS, Colo.--(HSMN NewsFeed)--Spectranetics (NASDAQ:SPNC ) announced the 12-month follow-up data from the CELLO study at the Leipzig Interventional Course (LINC) meeting held last week in Leipzig, Germany. The data was presented by Dr. Rajesh Dave, principal investigator of the CELLO trial and chairman, Endovascular Medicine, Pinnacle Health Heart and Vascular Institute at Harrisburg Hospital in Harrisburg, Pennsylvania.
The CELLO study is a prospective, multi-center registry which enrolled 65 patients treated with directed laser ablation of lesions of the superficial femoral arteries and popliteal arteries using the TURBO-Booster device. The primary endpoint of the study, which has been previously reported, was the percentage reduction in the stenosis prior to adjunctive therapy. Prior to treatment, the mean stenosis, or blockage, as measured by an independent core lab, was 77%. The mean stenosis following use of the TURBO-Booster was 42% and 21% after adjunctive therapy, which was either balloon angioplasty or balloon angioplasty and stenting. Stenting was performed in only 23% of the procedures. Of these patients, 86% and 78% were free from a repeat intervention at six and 12 months post-procedure, respectively. Patency as measured by duplex ultrasound was 59% and 54% at six and 12 months post-procedure, respectively. The primary safety endpoint was major adverse cardiac events at six months. No major adverse cardiac events occurred at six months. Measures of functional improvement included change in Rutherford class, walking impairment and ankle-brachial index, which all showed improvement at six months compared to baseline. Improvement was maintained in all three of these functional measures through the 12 month follow-up. All data from the CELLO trial has been submitted by Spectranetics to the Food and Drug Administration, which has accepted the data as part of the process to conclude the study.
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COLORADO SPRINGS, Colo.--(HSMN NewsFeed)--Spectranetics (NASDAQ:SPNC ) announced the 12-month follow-up data from the CELLO study at the Leipzig Interventional Course (LINC) meeting held last week in Leipzig, Germany. The data was presented by Dr. Rajesh Dave, principal investigator of the CELLO trial and chairman, Endovascular Medicine, Pinnacle Health Heart and Vascular Institute at Harrisburg Hospital in Harrisburg, Pennsylvania.
The CELLO study is a prospective, multi-center registry which enrolled 65 patients treated with directed laser ablation of lesions of the superficial femoral arteries and popliteal arteries using the TURBO-Booster device. The primary endpoint of the study, which has been previously reported, was the percentage reduction in the stenosis prior to adjunctive therapy. Prior to treatment, the mean stenosis, or blockage, as measured by an independent core lab, was 77%. The mean stenosis following use of the TURBO-Booster was 42% and 21% after adjunctive therapy, which was either balloon angioplasty or balloon angioplasty and stenting. Stenting was performed in only 23% of the procedures. Of these patients, 86% and 78% were free from a repeat intervention at six and 12 months post-procedure, respectively. Patency as measured by duplex ultrasound was 59% and 54% at six and 12 months post-procedure, respectively. The primary safety endpoint was major adverse cardiac events at six months. No major adverse cardiac events occurred at six months. Measures of functional improvement included change in Rutherford class, walking impairment and ankle-brachial index, which all showed improvement at six months compared to baseline. Improvement was maintained in all three of these functional measures through the 12 month follow-up. All data from the CELLO trial has been submitted by Spectranetics to the Food and Drug Administration, which has accepted the data as part of the process to conclude the study.
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Tuesday, January 20, 2009
New Start-up AeonClad Biomedical Applies Patented Coatings Technology AeonCoat(TM) to the Drug Delivery and Medical Devices Markets
AUSTIN, TX – January 19, 2009 - Specialty coatings company, AeonClad Coatings LLC, has announced the launch of a newly formed subsidiary, AeonClad Biomedical LLC. The new company will focus on biomedical applications utilizing the AeonCoat™ Technology. AeonCoat is a dry coating technology that offers a single-step, solvent-free process producing conformal films. The technology enables custom tailored coatings allowing for improved dissolution of poorly water soluble drugs, as well as modified or sustained release. Coatings can also display functional groups used for secondary covalent coupling of biological materials or for targeted drug delivery.
Key Markets and Business Development By concentrating on drug delivery and medical devices, AeonClad Biomedical is positioned to meet key market needs. The Nanotechnology-based drug delivery market is expected to garner $700-$800 billion revenues by 2015.? Expectations are that the market will be driven by the expanding horizon of therapeutic applications. Venture capital investments in nanotechnology drug delivery companies have been increasing and have provided further positive spin to the market growth.
Full article >> http://www.devicespace.com/news_story.aspx?NewsEntityId=123296
Key Markets and Business Development By concentrating on drug delivery and medical devices, AeonClad Biomedical is positioned to meet key market needs. The Nanotechnology-based drug delivery market is expected to garner $700-$800 billion revenues by 2015.? Expectations are that the market will be driven by the expanding horizon of therapeutic applications. Venture capital investments in nanotechnology drug delivery companies have been increasing and have provided further positive spin to the market growth.
Full article >> http://www.devicespace.com/news_story.aspx?NewsEntityId=123296
Stents Can Treat - Not Just Prevent - Strokes, Suggests Early Research
HOLLYWOOD, Fla., Jan. 19 /PRNewswire/ -- Stents can be placed in the brain to treat a stroke as it's occurring, suggests preliminary data being presented at the 21st Annual International Symposium on Endovascular Therapy (ISET).
Stents have long been used to open up blocked blood vessels in the heart to prevent heart attacks and in the neck to prevent strokes. More recently stents have been used in the heart to treat occurring heart attacks by opening up the blocked arteries. This early research suggests stents also can be used to treat occurring strokes, by opening up blocked arteries in the brain.
Treatments for ischemic stroke currently include delivering clot-busting drugs to the blockage through the veins or directly into the clot through an artery, or by removing the clot with a tiny corkscrew-like device or vacuuming it out. But early research suggests stents may work better than those treatments.
Full article>> http://news.prnewswire.com/DisplayReleaseContent.aspx?ACCT=104&STORY=/www/story/01-19-2009/0004956968&EDATE=
Stents have long been used to open up blocked blood vessels in the heart to prevent heart attacks and in the neck to prevent strokes. More recently stents have been used in the heart to treat occurring heart attacks by opening up the blocked arteries. This early research suggests stents also can be used to treat occurring strokes, by opening up blocked arteries in the brain.
Treatments for ischemic stroke currently include delivering clot-busting drugs to the blockage through the veins or directly into the clot through an artery, or by removing the clot with a tiny corkscrew-like device or vacuuming it out. But early research suggests stents may work better than those treatments.
Full article>> http://news.prnewswire.com/DisplayReleaseContent.aspx?ACCT=104&STORY=/www/story/01-19-2009/0004956968&EDATE=
RaySearch and Nucletron expand collaboration with two new solutions for treatment planning
STOCKHOLM, Sweden--Jan 20, 2009 - (HSMN NewsFeed) - RaySearch Laboratories AB (STO:RAYB) and Nucletron BV have extended their existing collaboration with two new treatment planning solutions for radiation therapy. According to a new development and license agreement, RaySearch will develop software modules for Model-Based Segmentation (MBS) and treatment planning of Volumetric Modulated Arc Therapy (VMAT) for Oncentra® MasterPlan, Nucletron’s multimodality treatment planning system.
VMAT is a relatively new and advanced form of Intensity Modulated Radiation Therapy (IMRT), in which the target is continuously irradiated while the source of the beam rotates around the patient in single or multiple arcs. This concept enables faster treatment delivery compared to traditional IMRT, where the patient is irradiated only from a few selected angles. At the same time, treatment quality remains similar or can be improved compared with traditional IMRT. The new VMAT treatment planning solution will be integrated in the Oncentra® Optimizer module of MasterPlan.
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VMAT is a relatively new and advanced form of Intensity Modulated Radiation Therapy (IMRT), in which the target is continuously irradiated while the source of the beam rotates around the patient in single or multiple arcs. This concept enables faster treatment delivery compared to traditional IMRT, where the patient is irradiated only from a few selected angles. At the same time, treatment quality remains similar or can be improved compared with traditional IMRT. The new VMAT treatment planning solution will be integrated in the Oncentra® Optimizer module of MasterPlan.
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Speakers focus on advances in cancer research in Israel
The most advanced diagnostic and treatment tools in the world are of no value to millions of people across the globe — because they don't have access to them.
As director of the Center for Bioengineering in the Service of Humanity and Society at Hebrew University of Jerusalem, Professor Boris Rubinsky is working to create inexpensive methods of diagnosing and treating disease.
Through research partnerships in Mexico and elsewhere, Rubinsky is developing a portable ultrasound machine that connects an ultrasound transducer, or sensor, to a cellular phone. Through this technology adaptation, a physician can travel to a rural clinic and transmit ultrasound images to a central office. That eliminates the need to purchase a $70,000 piece of equipment in every town the physician visits, according to Rubinsky. "Medical imaging is not available to about three-quarters of the world's population and it turns out big chunks of that population does have access to cellular phone technology because it doesn't require an infrastructure," Rubinsky said.
Full text>> http://www.palmbeachdailynews.com/news/content/news/2009/01/18/HebrewTWO0119.html
As director of the Center for Bioengineering in the Service of Humanity and Society at Hebrew University of Jerusalem, Professor Boris Rubinsky is working to create inexpensive methods of diagnosing and treating disease.
Through research partnerships in Mexico and elsewhere, Rubinsky is developing a portable ultrasound machine that connects an ultrasound transducer, or sensor, to a cellular phone. Through this technology adaptation, a physician can travel to a rural clinic and transmit ultrasound images to a central office. That eliminates the need to purchase a $70,000 piece of equipment in every town the physician visits, according to Rubinsky. "Medical imaging is not available to about three-quarters of the world's population and it turns out big chunks of that population does have access to cellular phone technology because it doesn't require an infrastructure," Rubinsky said.
Full text>> http://www.palmbeachdailynews.com/news/content/news/2009/01/18/HebrewTWO0119.html
Monday, January 19, 2009
AngioDynamics to Sponsor Symposium on First Human Clinical Experience with IRE Technology
QUEENSBURY, N.Y.--(BUSINESS WIRE)--AngioDynamics Inc. (NASDAQ:ANGO - News), a leading provider of innovative medical devices used by interventional radiologists, nephrologists and surgeons for the minimally invasive treatment of cancer and peripheral vascular disease, announced today that it will sponsor a symposium in New York City on January 22 during which doctors who have performed procedures using the Company’s recently-introduced NanoKnife™ system will share their experiences and patient outcomes.
NanoKnife is the first product offered by AngioDynamics that uses the new, potentially groundbreaking irreversible electroporation (IRE) technology. IRE technology is a non-thermal ablation technique for the resection of soft tissue. It has been described as “surgery at the cellular level.” The NanoKnife system uses electrical fields to create nano-scale defects in the membranes of targeted soft tissue, causing cell death only in the targeted tissue, without destroying critical structures such as ducts, blood vessels and nerves nearby.
Press release >> http://biz.yahoo.com/bw/090116/20090116005095.html?.v=1
NanoKnife is the first product offered by AngioDynamics that uses the new, potentially groundbreaking irreversible electroporation (IRE) technology. IRE technology is a non-thermal ablation technique for the resection of soft tissue. It has been described as “surgery at the cellular level.” The NanoKnife system uses electrical fields to create nano-scale defects in the membranes of targeted soft tissue, causing cell death only in the targeted tissue, without destroying critical structures such as ducts, blood vessels and nerves nearby.
Press release >> http://biz.yahoo.com/bw/090116/20090116005095.html?.v=1
SurgiQuest Signs a Development and Supply Agreement with Intuitive Surgical for MIS Access Utilizing the AirSeal(TM) Technology
ORANGE, Conn., Jan. 19 (HSMN NewsFeed) -- SurgiQuest, Inc. is pleased to announce it has entered into a development and supply agreement with Intuitive Surgical, Inc. (Nasdaq: ISRG ) in which SurgiQuest will develop a disposable access system using AirSeal(TM) technology for use with Intuitive's laparoscopic surgical robot.
SurgiQuest's technology offers superior access during minimally invasive surgical procedures because it allows the surgeon to operate with an unprecedented degree of freedom. The AirSeal system accommodates multiple instruments of any shape or size through a single port simultaneously. In addition to stable pneumoperitoneum, surgeons have expressed a preference for the platform on the basis that it facilitates unencumbered access and visualization.
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SurgiQuest's technology offers superior access during minimally invasive surgical procedures because it allows the surgeon to operate with an unprecedented degree of freedom. The AirSeal system accommodates multiple instruments of any shape or size through a single port simultaneously. In addition to stable pneumoperitoneum, surgeons have expressed a preference for the platform on the basis that it facilitates unencumbered access and visualization.
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A Milestone in Cancer Genetics: deCODE Discovers First Common Genetic Variants Affecting the Risk of Many Types of Cancer
Findings point to common mechanisms of susceptibility to cancers of the lung, bladder, prostate, cervix and skin; findings to be integrated into deCODEme(TM), the new deCODEme Cancer Scan(TM), and deCODE's DNA-based risk diagnostic tests
REYKJAVIK, Iceland, Jan. 18 (HSMN NewsFeed) -- Scientists at deCODE genetics (Nasdaq: DCGN ) and colleagues from the US and ten European countries today announced a long-awaited first in cancer research: the discovery of common single-letter variations in the human genome (SNPs) linked to susceptibility not of one, but several different types of cancer, including those of lung, bladder, prostate, skin and cervix.
Over the past two years, deCODE has led a wave of discoveries by scientists around the world of common SNPs conferring risk of many major types of cancer. Yet without exception, these SNPs have been linked to cancer of only one or at most two tissue types or organs. The SNPs published today, located near each other on chromosome 5p15, may therefore help to tag major biological mechanisms underlying cancer susceptibility more generally. The paper, entitled "Sequence variants at the TERT-CLPTM1L locus associate with many cancer types," is published today in the online edition of Nature Genetics at www.nature.com/ng, and will appear in an upcoming print edition of the journal.
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REYKJAVIK, Iceland, Jan. 18 (HSMN NewsFeed) -- Scientists at deCODE genetics (Nasdaq: DCGN ) and colleagues from the US and ten European countries today announced a long-awaited first in cancer research: the discovery of common single-letter variations in the human genome (SNPs) linked to susceptibility not of one, but several different types of cancer, including those of lung, bladder, prostate, skin and cervix.
Over the past two years, deCODE has led a wave of discoveries by scientists around the world of common SNPs conferring risk of many major types of cancer. Yet without exception, these SNPs have been linked to cancer of only one or at most two tissue types or organs. The SNPs published today, located near each other on chromosome 5p15, may therefore help to tag major biological mechanisms underlying cancer susceptibility more generally. The paper, entitled "Sequence variants at the TERT-CLPTM1L locus associate with many cancer types," is published today in the online edition of Nature Genetics at www.nature.com/ng, and will appear in an upcoming print edition of the journal.
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Court of Appeals Overturns 2005 Patent Verdict Against Cordis
WARREN, N.J., Jan. 15 (HSMN NewsFeed) -- The Court of Appeals for the Federal Circuit in Washington, D.C. today found Boston Scientific Corporation's Ding patent invalid, and reversed a 2005 jury finding that Cordis Corporation's CYPHER® Sirolimus-eluting Coronary Stent infringed that patent.
Cordis is very pleased with this significant Court decision.The original jury verdict was rendered in July 2005 in Wilmington, Delaware. The Ding patent had claimed a two-layer drug coating for a drug-eluting stent, which the Appeals Court found to be obvious in light of earlier issued patents.
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Cordis is very pleased with this significant Court decision.The original jury verdict was rendered in July 2005 in Wilmington, Delaware. The Ding patent had claimed a two-layer drug coating for a drug-eluting stent, which the Appeals Court found to be obvious in light of earlier issued patents.
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Thursday, January 15, 2009
Research and Markets: A Dynamic Online Journal for Radiologists in Oncologic Imaging
Dublin - Research and Markets (http://www.researchandmarkets.com/research/7f6155/cancer_imaging) has announced the addition of the "Cancer Imaging" report to their offering.
Cancer Imaging is the official Journal of the International Cancer Imaging Society (ICIS) and speedily publishes invited reviews, peer-reviewed original articles, case reports and pictorial reviews, plus editorials by leading experts from around the world.
Topics covered include state-of-the-art CT-, MR- and PET-imaging in all kinds of malignant tumours, including new developments, techniques and innovations.
Full article >> http://biz.yahoo.com/bw/090114/20090114005493.html?.v=1
Cancer Imaging is the official Journal of the International Cancer Imaging Society (ICIS) and speedily publishes invited reviews, peer-reviewed original articles, case reports and pictorial reviews, plus editorials by leading experts from around the world.
Topics covered include state-of-the-art CT-, MR- and PET-imaging in all kinds of malignant tumours, including new developments, techniques and innovations.
Full article >> http://biz.yahoo.com/bw/090114/20090114005493.html?.v=1
Nephros, Inc. Receives the 2009 Frost & Sullivan Medical Device Patient Care Company of the Year Award
RIVER EDGE, N.J., Jan. 14 /PRNewswire-FirstCall/ -- Nephros, Inc. (Amex: NEP), is pleased to announce that it has received the prestigious 2009 Frost & Sullivan Medical Device Patient Care Company of the Year Award, for its rapid growth, progressive technology, and strategic product development.
Nephros was recognized for its ability to develop products that meet market demands. Nephros's breakthrough hemodiafiltration technology has resulted in rapid revenue growth as well as a new therapy for end-stage renal disease (ESRD). Its OLpur(TM) H2H(TM) Module and MD 220 filter received approval under an investigational device exemption (IDE) from the FDA in January 2007. By October, clinical trials were initiated at the Columbia University Dialysis Center in New York. In June 2008, Nephros completed a pivotal trial for its hemodiafiltration products and submitted a 510(k) application in November.
Full article >> http://news.prnewswire.com/ViewContent.aspx?ACCT=109&STORY=/www/story/01-14-2009/0004954634&EDATE=
Nephros was recognized for its ability to develop products that meet market demands. Nephros's breakthrough hemodiafiltration technology has resulted in rapid revenue growth as well as a new therapy for end-stage renal disease (ESRD). Its OLpur(TM) H2H(TM) Module and MD 220 filter received approval under an investigational device exemption (IDE) from the FDA in January 2007. By October, clinical trials were initiated at the Columbia University Dialysis Center in New York. In June 2008, Nephros completed a pivotal trial for its hemodiafiltration products and submitted a 510(k) application in November.
Full article >> http://news.prnewswire.com/ViewContent.aspx?ACCT=109&STORY=/www/story/01-14-2009/0004954634&EDATE=
Hospitals, Healthcare Providers to Save with Premier Diagnostic, Interventional Radiology and Peripheral, Biliary Stent Agreements
CHARLOTTE, N.C.--(BUSINESS WIRE)--January 14, 2009--Premier Purchasing Partners, LP, today announced new agreements in two categories: diagnostic and interventional radiology, and peripheral and biliary stents.
In the diagnostic and interventional radiology portfolio, contracts were awarded to Bard Peripheral Vascular Inc. of Tempe, Ariz.; Boston Scientific Corporation of Natick, Mass.; and Cook Medical Inc. of Bloomington, Ind.
In the peripheral and biliary stents portfolio, contracts were awarded to Abbott Laboratories Inc., Abbott Vascular of Abbott Park, Ill.; Boston Scientific Corporation and ev3 Endovascular Inc. of Plymouth, Minn.
Effective January 1, 2009, the 13-month agreements are available to acute and continuum of care members of the Premier healthcare alliance.
Press release >> http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20090114005050&newsLang=en
In the diagnostic and interventional radiology portfolio, contracts were awarded to Bard Peripheral Vascular Inc. of Tempe, Ariz.; Boston Scientific Corporation of Natick, Mass.; and Cook Medical Inc. of Bloomington, Ind.
In the peripheral and biliary stents portfolio, contracts were awarded to Abbott Laboratories Inc., Abbott Vascular of Abbott Park, Ill.; Boston Scientific Corporation and ev3 Endovascular Inc. of Plymouth, Minn.
Effective January 1, 2009, the 13-month agreements are available to acute and continuum of care members of the Premier healthcare alliance.
Press release >> http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20090114005050&newsLang=en
Medical sales school greets students
Jan. 13--Not every party offers the sight of bloody surgical films playing on video screens, but it somehow seemed appropriate for the grand opening of the American Institute of Medical Sales.
The Sunday night party and ribbon-cutting ceremony marked the arrival of the first 13 students at the new school, which will train them how to sell products such as artificial hips and knees.
The students have been taking online courses for four weeks and will be taking courses for another four in Memphis, shuttling between the class space tucked into a strip mall near the Wolfchase Galleria and a nearby extended stay hotel.
Once they're done with the coursework and dry runs in the school's mock operating room, they'll head out for jobs as orthopedic medical device sales reps.
Full article >> http://login.newsedge.com/newsedge.asp?site=2006120112282907013819&2008021217172207938349=on%2C&briefs=off&display=MDL+Top+Stories&folderaction=viewhtml&rtcrdata=on&block=html&mode=displaystory&synapseid=2008021217172207938349&storyid=200901131180.3.125_3b000000002e23be
The Sunday night party and ribbon-cutting ceremony marked the arrival of the first 13 students at the new school, which will train them how to sell products such as artificial hips and knees.
The students have been taking online courses for four weeks and will be taking courses for another four in Memphis, shuttling between the class space tucked into a strip mall near the Wolfchase Galleria and a nearby extended stay hotel.
Once they're done with the coursework and dry runs in the school's mock operating room, they'll head out for jobs as orthopedic medical device sales reps.
Full article >> http://login.newsedge.com/newsedge.asp?site=2006120112282907013819&2008021217172207938349=on%2C&briefs=off&display=MDL+Top+Stories&folderaction=viewhtml&rtcrdata=on&block=html&mode=displaystory&synapseid=2008021217172207938349&storyid=200901131180.3.125_3b000000002e23be
Novadaq Signs License, Development and Supply Agreements With Intuitive
SPY Imaging Technology to be Integrated Into da Vinci Surgical RobotsTORONTO, ONTARIO--(HSMN NewsFeed)--Jan 14, 2009 -- Novadaq® Technologies Inc. (Toronto:NDQ.TO ), announced today that it has entered into a multi-year technology alliance with Intuitive Surgical Inc. Novadaq is a developer of real-time medical imaging systems and image guided therapies for the operating room. Intuitive is the global leader in the rapidly emerging field of robotic-assisted minimally invasive surgery.
In the fourth quarter of 2007, the two companies began exploring the use of Novadaq's patented SPY® fluorescence imaging technology during minimally invasive surgical robotic procedures to potentially enable surgeons to visualize blood flow in vessels, tissue perfusion, tumors, tumor margins, and the lymphatic system in real-time. That collaboration has now resulted in the signing of two multi-year agreements between the companies.
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In the fourth quarter of 2007, the two companies began exploring the use of Novadaq's patented SPY® fluorescence imaging technology during minimally invasive surgical robotic procedures to potentially enable surgeons to visualize blood flow in vessels, tissue perfusion, tumors, tumor margins, and the lymphatic system in real-time. That collaboration has now resulted in the signing of two multi-year agreements between the companies.
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Wednesday, January 14, 2009
Clarient, Inc. Launches Gene Expression Test for Prostate Cancer
ALISO VIEJO, Calif.--(BUSINESS WIRE)--Clarient, Inc. (Nasdaq: CLRT - News), a premier anatomic pathology and molecular testing services resource for pathologists, oncologists, and the pharmaceutical industry, today announced the commercial launch of its new gene expression test for prostate cancer. This new test will be available through Clarient’s PATHSiTETM virtual reporting tool and accessible to the company’s entire pathology network
Clarient’s new test is based on a unique and patent protected combination of four genes that have been shown to accurately identify the presence of Grade 3 or higher (clinically significant cancer) prostate cancer cells in prostate tissue. The association of these four genes with prostate cancer was discovered by Health Discovery Corporation (OTCBB: HDVY - News) using their patented SVM and SVM-RFE pattern recognition technology.
Full article >> http://www.devicespace.com/news_story.aspx?NewsEntityId=122689
Clarient’s new test is based on a unique and patent protected combination of four genes that have been shown to accurately identify the presence of Grade 3 or higher (clinically significant cancer) prostate cancer cells in prostate tissue. The association of these four genes with prostate cancer was discovered by Health Discovery Corporation (OTCBB: HDVY - News) using their patented SVM and SVM-RFE pattern recognition technology.
Full article >> http://www.devicespace.com/news_story.aspx?NewsEntityId=122689
Invatec Launches First Drug-Eluting Balloon Designed to Treat Atherosclerosis Below the Knee
LEIPZIG, Germany--(BUSINESS WIRE)--Invatec, a comprehensive innovator of interventional products, today announced the European launch of a new peripheral balloon, the IN.PACT™ Amphirion paclitaxel-eluting PTA balloon catheter. This is the first drug-eluting catheter designed specifically to treat atherosclerosis in arteries located below the knee (BtK). IN.PACT features FreePac™, a proprietary coating that frees and separates paclitaxel molecules and facilitates their absorption into the wall of the artery.
The FreePac coating was developed in close collaboration with the researchers who pioneered drug-eluting balloon therapy, Ulrich Speck, Ph.D., Department of Radiology at Charite Mitte, Berlin and Bruno Scheller, M.D., University Hospital, Department of Internal Medicine, Homburg/Saar. “According to research published in the New England Journal of Medicine1 and Circulation2, drug-eluting balloons utilizing a special drug elution formulation have demonstrated effectiveness in the treatment of atherosclerosis and the prevention of restenosis,” commented Andrea Venturelli and Stefan Widensohler, co-founders of Invatec. “Invatec is taking this approach further by offering a drug elution therapy targeted specifically for below the knee interventions and placing it on a market-leading, state-of-the-art platform, the Amphirion Deep balloon catheter.”
Full article >> http://www.devicespace.com/news_story.aspx?NewsEntityId=122850
The FreePac coating was developed in close collaboration with the researchers who pioneered drug-eluting balloon therapy, Ulrich Speck, Ph.D., Department of Radiology at Charite Mitte, Berlin and Bruno Scheller, M.D., University Hospital, Department of Internal Medicine, Homburg/Saar. “According to research published in the New England Journal of Medicine1 and Circulation2, drug-eluting balloons utilizing a special drug elution formulation have demonstrated effectiveness in the treatment of atherosclerosis and the prevention of restenosis,” commented Andrea Venturelli and Stefan Widensohler, co-founders of Invatec. “Invatec is taking this approach further by offering a drug elution therapy targeted specifically for below the knee interventions and placing it on a market-leading, state-of-the-art platform, the Amphirion Deep balloon catheter.”
Full article >> http://www.devicespace.com/news_story.aspx?NewsEntityId=122850
NuVasive Announces Investment in Novel Orthobiologic Company
SAN DIEGO, Jan. 13 /PRNewswire-FirstCall/ -- NuVasive, Inc. (Nasdaq: NUVA), a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced today that it has agreed to make an investment in Progentix Orthobiology BV, a Netherlands based company focused on developing novel orthobiologics.
This investment marks NuVasive's third strategic transaction in the biologics arena, amplifying the company's offering with a synthetic bone substitute technology that has the potential to compete with any biologic on the market today. Progentix is developing a synthetic bone substitute that is designed to accelerate bone healing through a novel micro-structure created by a proprietary manufacturing process.
Full text >> http://dialog.newsedge.com/portal.asp?site=2006120112282907013819&portlet=ep&searchfolderid=pg2006120112305702055933&action=sitetopics&block=portaldefault&related=off&searchid=2919&storyid=p0114814.0rw&rtcrdata=off
This investment marks NuVasive's third strategic transaction in the biologics arena, amplifying the company's offering with a synthetic bone substitute technology that has the potential to compete with any biologic on the market today. Progentix is developing a synthetic bone substitute that is designed to accelerate bone healing through a novel micro-structure created by a proprietary manufacturing process.
Full text >> http://dialog.newsedge.com/portal.asp?site=2006120112282907013819&portlet=ep&searchfolderid=pg2006120112305702055933&action=sitetopics&block=portaldefault&related=off&searchid=2919&storyid=p0114814.0rw&rtcrdata=off
Merit Medical Announces Microcatheter Market Entry
SOUTH JORDAN, Utah, Jan. 14, 2009 -- (HSMN NewsFeed) -- Merit Medical Systems, Inc. (NasdaqGS:MMSI ), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology and radiology procedures, announced today that it will enter the microcatheter market with the introduction of the Merit Maestro(tm) Microcatheter. The Company recently received 510(k) clearance for the microcatheter from the Food and Drug Administration.
Microcatheters are used to deliver various diagnostic, embolic and therapeutic materials to treat uterine fibroids, hypervascularized tumors and vascular malformations.``The introduction of this microcatheter product line complements Merit's presence in interventional radiology procedures,'' said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer. ``Many of Merit's existing products can be combined at the same point of sale. Just over a year ago Merit acquired other microcatheter assets and will develop additional products over the next several years.''
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Microcatheters are used to deliver various diagnostic, embolic and therapeutic materials to treat uterine fibroids, hypervascularized tumors and vascular malformations.``The introduction of this microcatheter product line complements Merit's presence in interventional radiology procedures,'' said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer. ``Many of Merit's existing products can be combined at the same point of sale. Just over a year ago Merit acquired other microcatheter assets and will develop additional products over the next several years.''
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Jennerex Appoints Samantha Miller as Vice President of Corporate Development
SAN FRANCISCO, Jan. 13 (HSMN NewsFeed) -- Jennerex, Inc. (San Francisco, CA and Ottawa, Canada) a clinical-stage biotherapeutics company, is pleased to announce that Samantha Miller has been appointed to the position of Vice President of Corporate Development.
Ms. Miller has over 15 years of biotechnology and pharmaceutical business development experience, and has negotiated, executed and managed numerous global partnerships, as well as regional partnerships in the United States, Europe, Japan and elsewhere. She has been involved in executing over 30 partnerships and licenses, with companies such as GlaxoSmithKline, Eli Lilly, Johnson & Johnson, AstraZeneca, Astellas and others.Ms. Miller has held senior positions in business development, including the title of Vice President, in various companies including Anesiva, Theravance, Scios Pharmaceuticals, Onyx Pharmaceuticals and Procter & Gamble Pharmaceuticals.
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Ms. Miller has over 15 years of biotechnology and pharmaceutical business development experience, and has negotiated, executed and managed numerous global partnerships, as well as regional partnerships in the United States, Europe, Japan and elsewhere. She has been involved in executing over 30 partnerships and licenses, with companies such as GlaxoSmithKline, Eli Lilly, Johnson & Johnson, AstraZeneca, Astellas and others.Ms. Miller has held senior positions in business development, including the title of Vice President, in various companies including Anesiva, Theravance, Scios Pharmaceuticals, Onyx Pharmaceuticals and Procter & Gamble Pharmaceuticals.
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AngioDynamics Acquires FlowMedica Benephit(R) Renal Therapy Product Line
Benephit Only FDA-Cleared Device to Address Acute Kidney Injury MarketQUEENSBURY, N.Y.--(HSMN NewsFeed)--Jan. 12, 2009--AngioDynamics Inc. (NASDAQ: ANGO), a leading provider of innovative medical devices used by interventional radiologists, nephrologists and surgeons for the minimally invasive treatment of cancer and peripheral vascular disease, announced today that it has purchased certain assets of privately-held FlowMedica Inc., a leader in the emerging field of Targeted Renal Therapy(TM) (TRT(R)). The transaction was structured as an asset purchase under which AngioDynamics will pay $1.75 million in cash for the assets of the business plus a contingent payment based on fiscal 2011 sales of Benephit products.
Pioneered by FlowMedica, TRT is a therapeutic approach that delivers drugs directly to the kidneys in order to prevent and treat acute kidney injury (AKI). AKI often results from many common interventional and surgical procedures, and is a significant problem in high renal risk patients such as the elderly and diabetics. Benephit infusion products deliver therapeutic agents directly into both renal arteries through dedicated infusion catheter and sheath systems while allowing simultaneous interventional coronary, peripheral, endovascular and surgical procedures. TRT can also be employed for stand-alone renal drug delivery in other hospital settings when desired. The Benephit systems have been granted 510(k) clearance from the FDA and the CE Mark, and are commercially available.
Press Release >> http://www.angiodynamics.com/pages/news/news_articles_detail.asp?id=284
Pioneered by FlowMedica, TRT is a therapeutic approach that delivers drugs directly to the kidneys in order to prevent and treat acute kidney injury (AKI). AKI often results from many common interventional and surgical procedures, and is a significant problem in high renal risk patients such as the elderly and diabetics. Benephit infusion products deliver therapeutic agents directly into both renal arteries through dedicated infusion catheter and sheath systems while allowing simultaneous interventional coronary, peripheral, endovascular and surgical procedures. TRT can also be employed for stand-alone renal drug delivery in other hospital settings when desired. The Benephit systems have been granted 510(k) clearance from the FDA and the CE Mark, and are commercially available.
Press Release >> http://www.angiodynamics.com/pages/news/news_articles_detail.asp?id=284
Allium Group Receives CE Mark for Its Next-Generation Prostatic Stent
World's only large caliber, removable prostatic stent designed to fit the anatomy and function of the prostatic urethra will be distributed throughout EuropeCAESAREA, Israel - January 12, 2009 - (HSMN NewsFeed) - Allium Group, the developer and manufacturer of innovative stents for the urinary, gastro-intestinal, pulmonary and peripheral vascular tracts, announced today that it has been awarded CE mark for its prostatic stent enabling commercialization of the system in the European Union and the countries that recognize the CE Mark.
"We are excited about receiving the European CE approval for our Prostatic stent. This achievement confirms the innovativeness and advantages of our stent technology and brings us closer to offering patients solutions that provide them with efficacious and immediate treatment, convenience, comfort and quality of life," said Limor Domnitz Gishri, CEO of Allium Medical. "Allium Medical has had a great deal of success in Europe with its biliary and ureteral stents that received CE marks and begun to market in 2007 and we believe that our prostatic stent will quickly become the "must have" solution for physicians and hospitals in Europe."
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"We are excited about receiving the European CE approval for our Prostatic stent. This achievement confirms the innovativeness and advantages of our stent technology and brings us closer to offering patients solutions that provide them with efficacious and immediate treatment, convenience, comfort and quality of life," said Limor Domnitz Gishri, CEO of Allium Medical. "Allium Medical has had a great deal of success in Europe with its biliary and ureteral stents that received CE marks and begun to market in 2007 and we believe that our prostatic stent will quickly become the "must have" solution for physicians and hospitals in Europe."
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Atrium Medical Announces Formation of Biosurgery Division
HUDSON, NH--(HSMN NewsFeed)--Jan 12, 2009 -- Atrium Medical Corporation® is pleased to announce the formation of its newest med-tech specialty healthcare division, Atrium Biosurgery(TM). Atrium Biosurgery is dedicated to the development of pioneering advancements in biological, mechanical and therapeutic solutions for soft tissue healing following trauma, surgery and or other interventional procedures that require improved patient recovery and prospects for improved healing outcomes. This newest global expansion will complement Atrium's other professional Healthcare Divisions -- Cardiovascular Interventions (CVI) and Cardiothoracic Surgery (CTS) -- by continuing the company's tradition of providing state-of-the-art medical device technology for patients around the globe.
Atrium Biosurgery products include Atrium's first-to-market Omega 3 Bioabsorbable Oil Fatty Acid (O3FA) coated medical devices. This novel technology combines Atrium's ProLite(TM) and ProLite Ultra(TM) brand polypropylene surgical mesh products commonly used in soft tissue and hernia repair with a proprietary, pharmaceutical grade Omega 3 bio-absorbable coating. Atrium's innovative discovery of combining an inert thin wall polypropylene mesh with an all natural Omega 3 biological coating in clinical use, and in numerous pre-clinical studies, has demonstrated minimization of visceral tissue attachment as well as reductions in both foreign body reaction and inflammation following surgical intervention. Such technology can result in a preferred, well healed, reinforced surgical repair. These soft tissue reinforcement devices include Atrium C-QUR(TM) Mesh, C-QUR Edge(TM) Mesh, and the recently launched C-QUR Lite(TM) Surgical Mesh which combine a proven inert polymer material with an advanced Omega 3 coating technology -- indicated for use in the surgical repair and reinforcement of soft tissue, including abdominal and inguinal hernia surgery, common surgical procedures performed more than 700,000 times annually in the US.
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Atrium Biosurgery products include Atrium's first-to-market Omega 3 Bioabsorbable Oil Fatty Acid (O3FA) coated medical devices. This novel technology combines Atrium's ProLite(TM) and ProLite Ultra(TM) brand polypropylene surgical mesh products commonly used in soft tissue and hernia repair with a proprietary, pharmaceutical grade Omega 3 bio-absorbable coating. Atrium's innovative discovery of combining an inert thin wall polypropylene mesh with an all natural Omega 3 biological coating in clinical use, and in numerous pre-clinical studies, has demonstrated minimization of visceral tissue attachment as well as reductions in both foreign body reaction and inflammation following surgical intervention. Such technology can result in a preferred, well healed, reinforced surgical repair. These soft tissue reinforcement devices include Atrium C-QUR(TM) Mesh, C-QUR Edge(TM) Mesh, and the recently launched C-QUR Lite(TM) Surgical Mesh which combine a proven inert polymer material with an advanced Omega 3 coating technology -- indicated for use in the surgical repair and reinforcement of soft tissue, including abdominal and inguinal hernia surgery, common surgical procedures performed more than 700,000 times annually in the US.
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Thermage, Inc. Announces Name Change to Solta Medical, Inc.
Launches Expanded Customer Loyalty Program Stock to Begin Trading Today Under 'SLTM'
HAYWARD, Calif., Jan. 12 (HSMN NewsFeed) -- Thermage, Inc. (Nasdaq: THRM ) announced that effective today it has changed its corporate name to Solta Medical, Inc. At the open of the NASDAQ exchange this morning, Solta Medical, Inc. will begin trading under the symbol "SLTM."
"The name and ticker symbol changes are a great start to the New Year and a key milestone in the integration of the acquisition of Reliant Technologies, Inc. The new company combines the industry's two leading brands, Thermage® and Fraxel®, under a new corporate name that will now form a global leader in aesthetic energy devices," said Stephen J. Fanning, Chairman of the Board, President and CEO. "Solta Medical will focus on providing superior anti-aging solutions for patients and physicians by offering the gold standard of care for tightening, contouring and resurfacing of the skin with Thermage and Fraxel treatments."Solta Medical also announced the expansion of its industry-exclusive customer loyalty program which allows physicians to lock-in preferred pricing for Thermage and Fraxel treatment tips along with other preferred customer benefits to help physicians grow their practices and increase practice profitability.
Sunday, January 11, 2009
Volcano Announces Closing of Axsun Technologies Acquisition
SAN DIEGO, Jan. 7 /PRNewswire-FirstCall/ -- Volcano Corporation (Nasdaq: VOLC), a leader in the development, manufacturing and sales of products for the diagnosis and treatment of coronary and peripheral artery disease, said today that it has closed its previously announced acquisition of Axsun Technologies, Inc.
Axsun is a leading developer and manufacturer of lasers and optical engines used in medical Optical Coherence Tomography (OCT) imaging systems and advanced photonic components and subsystems used in other industrial applications.
Full article >> Volcano Announces Closing of Axsun Technologies Acquisition
Axsun is a leading developer and manufacturer of lasers and optical engines used in medical Optical Coherence Tomography (OCT) imaging systems and advanced photonic components and subsystems used in other industrial applications.
Full article >> Volcano Announces Closing of Axsun Technologies Acquisition
Aptus Endosystems Completes $30 Million Series C Financing
Looks to Commercialization of Pioneering Endovascular Treatment
for Abdominal Aortic Aneurysms
Sunnyvale, CA — January 7, 2009 — Aptus Endosystems Inc., a medical device company developing advanced technology for the endovascular treatment of aortic aneurysms, today announced it has closed a $30 Million Series C financing.
"The Aortic Aneurysm Repair market is a significant opportunity with over $800M in worldwide sales in 2008, and growing. Aptus has successfully developed proprietary endograft and fixation technologies that more closely approximate how a surgeon performs open surgical repair of aortic aneurysms, the current gold standard for treatment. These technologies allow the physician to perform an endovascular repair that is more durable, more compliant and more applicable to a broader patient population. This positions Aptus for significant growth in the AAA market and our investors have recognized the value of what significant clinical outcomes and advanced technology development can produce." said Bob H. Katz, President & CEO, Aptus Endosystems Inc. "
Press Release >> http://www.aptusendosystems.com/News/Aptus%20Endosystems%20Funding%20Release%20-%20FINAL%201-7-09.pdf
for Abdominal Aortic Aneurysms
Sunnyvale, CA — January 7, 2009 — Aptus Endosystems Inc., a medical device company developing advanced technology for the endovascular treatment of aortic aneurysms, today announced it has closed a $30 Million Series C financing.
"The Aortic Aneurysm Repair market is a significant opportunity with over $800M in worldwide sales in 2008, and growing. Aptus has successfully developed proprietary endograft and fixation technologies that more closely approximate how a surgeon performs open surgical repair of aortic aneurysms, the current gold standard for treatment. These technologies allow the physician to perform an endovascular repair that is more durable, more compliant and more applicable to a broader patient population. This positions Aptus for significant growth in the AAA market and our investors have recognized the value of what significant clinical outcomes and advanced technology development can produce." said Bob H. Katz, President & CEO, Aptus Endosystems Inc. "
Press Release >> http://www.aptusendosystems.com/News/Aptus%20Endosystems%20Funding%20Release%20-%20FINAL%201-7-09.pdf
FDA scientists complain to Obama of 'corruption'
WASHINGTON (AP) — In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.
"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, dated Wednesday and written on the agency's Center for Devices and Radiological Health letterhead.
The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA's drug review division a few years ago during the safety debacle involving the painkiller Vioxx.
The FDA declined to publicly respond to the letter, but said it is working to address the concerns.
In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.
Full article >> http://www.google.com/hostednews/ap/article/ALeqM5gfVw6WQl1LXeJz_XEnJRGuHAzTVwD95J8N980
"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, dated Wednesday and written on the agency's Center for Devices and Radiological Health letterhead.
The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA's drug review division a few years ago during the safety debacle involving the painkiller Vioxx.
The FDA declined to publicly respond to the letter, but said it is working to address the concerns.
In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.
Full article >> http://www.google.com/hostednews/ap/article/ALeqM5gfVw6WQl1LXeJz_XEnJRGuHAzTVwD95J8N980
Stryker Endoscopy Launches the World's First High-Definition Wireless Surgical Display With AMIMON's High-Definition Wireless Technology
SANTA CLARA, CA--(HSMN NewsFeed)--Dec 30, 2008 -- AMIMON Inc. is pleased to announce that Stryker Endoscopy, a division of Stryker Corporation, has launched the world's first high-definition (HD) wireless video display for the operating room. Stryker Endoscopy's WiSe(TM) HDTV is embedded with AMIMON's wireless HD technology. AMIMON has granted Stryker Endoscopy exclusive access to its technology for the medical endoscopy market.
"Stryker Endoscopy is known for providing best-in-class high-definition visualization for surgeons," said William Chang, Stryker Endoscopy's vice president of research and development and chief technology officer. "Only AMIMON's high-definition wireless technology is capable of transmitting surgical video with no perceptible lag or interference throughout the entire operating room. This will allow surgeons greater flexibility in positioning the surgical display while operating. In addition, hospitals and surgery centers will save the hassle and cost of routing DVI cables through the ceilings and overhead booms."
http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2026824
"Stryker Endoscopy is known for providing best-in-class high-definition visualization for surgeons," said William Chang, Stryker Endoscopy's vice president of research and development and chief technology officer. "Only AMIMON's high-definition wireless technology is capable of transmitting surgical video with no perceptible lag or interference throughout the entire operating room. This will allow surgeons greater flexibility in positioning the surgical display while operating. In addition, hospitals and surgery centers will save the hassle and cost of routing DVI cables through the ceilings and overhead booms."
http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2026824
First U.S. Implants of Newly Approved Embozene(TM) Color-Advanced Microspheres Embolization Platform
New Color-Coded Embolic with Polyzene(R)-F Coating Enhances Procedural Safety, Efficiency during Treatment of Hypervascularized Tumors and Arteriovenous Malformations
NEWNAN, Ga., Dec. 31 (HSMN NewsFeed) -- Against the backdrop of a flagging economy, bailouts, and bleak predictions, there is a biotechnology firm in suburban Atlanta with a future as bright as New Year's Eve fireworks. Only days after receiving FDA approval to market the Embozene(TM) Color-Advanced Microspheres embolization platform for the treatment of hypervascularized tumors (tumors with a large number of blood vessels in many locations) and arteriovenous malformations (defects in the circulatory system), CeloNova BioSciences today announced that the product has been successfully used to treat several patients at two Atlanta area hospitals: Emory-Adventist Hospital in Smyrna and WellStar Windy Hill Hospital in Marietta.
Dr. John Lipman, who performed the procedures at both hospitals, said, "I was really impressed with the Embozene(TM) Color-Advanced Microspheres. The material handled well, going immediately into suspension and, importantly, staying in suspension. The fact that Embozene(TM) Microspheres are color coded to size is an appealing feature that allows good visibility of the material and clearly creates a higher and important safety profile. CeloNova has apparently carefully engineered these beads to be extremely 'friendly' for the physician to use. I found in these first patients that the product was highly manageable during the procedure. I achieved the procedural goals to devascularize the tumors quickly, using much less material than other products, having far less radiation time for the patient, and requiring less contrast media. These are all important and present features."
Full article >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2026832
NEWNAN, Ga., Dec. 31 (HSMN NewsFeed) -- Against the backdrop of a flagging economy, bailouts, and bleak predictions, there is a biotechnology firm in suburban Atlanta with a future as bright as New Year's Eve fireworks. Only days after receiving FDA approval to market the Embozene(TM) Color-Advanced Microspheres embolization platform for the treatment of hypervascularized tumors (tumors with a large number of blood vessels in many locations) and arteriovenous malformations (defects in the circulatory system), CeloNova BioSciences today announced that the product has been successfully used to treat several patients at two Atlanta area hospitals: Emory-Adventist Hospital in Smyrna and WellStar Windy Hill Hospital in Marietta.
Dr. John Lipman, who performed the procedures at both hospitals, said, "I was really impressed with the Embozene(TM) Color-Advanced Microspheres. The material handled well, going immediately into suspension and, importantly, staying in suspension. The fact that Embozene(TM) Microspheres are color coded to size is an appealing feature that allows good visibility of the material and clearly creates a higher and important safety profile. CeloNova has apparently carefully engineered these beads to be extremely 'friendly' for the physician to use. I found in these first patients that the product was highly manageable during the procedure. I achieved the procedural goals to devascularize the tumors quickly, using much less material than other products, having far less radiation time for the patient, and requiring less contrast media. These are all important and present features."
Full article >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2026832
Medtronic Announces Clinical Trial of Stent for Peripheral Arterial Disease
Growing Research Program Underscores Company Commitment to PAD
MINNEAPOLIS--(HSMN NewsFeed)--Consistent with its commitment to addressing unmet patient needs, Medtronic, Inc. (NYSE: MDT ), today announced the first enrollment in the company’s FDA-approved clinical trial of its self-expanding (SE) Complete SE stent for the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA).
According to the Peripheral Arterial Disease Coalition, PAD of the lower extremities affects approximately eight million people in the United States, although many patients are unaware of their condition or the seriousness of it. PAD patients have a two- to six-fold increase in cardiovascular mortality and a significantly increased risk of amputation, disability and diminished quality of life, the PAD Coalition reports.“Medtronic’s clinical research program for peripheral arterial disease demonstrates a strong commitment to helping physicians and their patients,” said the study’s principal investigator, Dr. John Laird of the Vascular Center at the University of California (UC) Davis. “Through three clinical trials currently underway, Medtronic is partnering with physicians worldwide to evaluate the safety and efficacy of its stents in the treatment of PAD.”
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MINNEAPOLIS--(HSMN NewsFeed)--Consistent with its commitment to addressing unmet patient needs, Medtronic, Inc. (NYSE: MDT ), today announced the first enrollment in the company’s FDA-approved clinical trial of its self-expanding (SE) Complete SE stent for the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA).
According to the Peripheral Arterial Disease Coalition, PAD of the lower extremities affects approximately eight million people in the United States, although many patients are unaware of their condition or the seriousness of it. PAD patients have a two- to six-fold increase in cardiovascular mortality and a significantly increased risk of amputation, disability and diminished quality of life, the PAD Coalition reports.“Medtronic’s clinical research program for peripheral arterial disease demonstrates a strong commitment to helping physicians and their patients,” said the study’s principal investigator, Dr. John Laird of the Vascular Center at the University of California (UC) Davis. “Through three clinical trials currently underway, Medtronic is partnering with physicians worldwide to evaluate the safety and efficacy of its stents in the treatment of PAD.”
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Two-Year Study Confirms Use of LeMaitre Vascular's Endovascular Stent Graft to Treat Thoracic Aortic Disease
BURLINGTON, Mass., Jan. 6, 2009 -- (HSMN NewsFeed) -- LeMaitre Vascular, Inc. (NasdaqGM:LMAT ) today announced the publication of a study in the Journal of Endovascular Therapy confirming the use of LeMaitre's endovascular thoracic stent graft in the treatment of thoracic aortic aneurysms and dissections. The two-year study was conducted by Lefeng Qu, MD and Dieter Raithel, MD of Nuremberg Southern Hospital.
LeMaitre Vascular's EndoFit Thoracic Stent Graft demonstrated 100% technical success in the study, a retrospective review of 87 patients undergoing endovascular repair of their thoracic aorta. There were no device- or aneurysm-related deaths and there was only a low incidence of device- or aneurysm-related complications.
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LeMaitre Vascular's EndoFit Thoracic Stent Graft demonstrated 100% technical success in the study, a retrospective review of 87 patients undergoing endovascular repair of their thoracic aorta. There were no device- or aneurysm-related deaths and there was only a low incidence of device- or aneurysm-related complications.
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DiFUSION Technologies Announces Company Launch Focused on Surgical Site Infections (SSIs)
DiFUSION to mitigate SSIs that affect an estimated 780,000 patients in the United States each yearAUSTIN, Texas – January 6, 2009 – (HSMN NewsFeed) - DiFUSION Technologies, Inc., a medical device company targeting the orthopaedic market, today announced its corporate launch. The company will focus on reducing the rising incidence of Surgical Site Infections (SSIs) in spinal surgeries.
“In large studies, five out of 100 spine cases result in SSIs often leading to second surgeries that are extremely costly and difficult for the patient,” said Dr. Matthew Geck, founder and board member of DiFUSION and leading orthopaedic surgeon in Austin, Texas. “DiFUSION will release a medical device in 2009 capable of killing 650 types of bacteria including antibiotic-resistant bacteria such as MRSA (also known as “Superbugs”) in the local surgical wound for up to four weeks following surgery.”
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“In large studies, five out of 100 spine cases result in SSIs often leading to second surgeries that are extremely costly and difficult for the patient,” said Dr. Matthew Geck, founder and board member of DiFUSION and leading orthopaedic surgeon in Austin, Texas. “DiFUSION will release a medical device in 2009 capable of killing 650 types of bacteria including antibiotic-resistant bacteria such as MRSA (also known as “Superbugs”) in the local surgical wound for up to four weeks following surgery.”
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Meridian Receives FDA Approval
VANCOUVER, BRITISH COLUMBIA--(HSMN NewsFeed)--Jan 7, 2009 -- Meridian Co., Ltd., (OTC BB:MRDAF.OB ) a company engaged in the research, development, manufacturing, and sales of advanced medical devices, is pleased to announce that they have received FDA clearance to market the Lapex BCS (Body Contouring System) laser device.
The FDA 510(k) Clearance has been granted based on our premarket notification for indications for the Use of "elevating tissue temperature and temporary relief of muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or temporary relaxation of muscle".
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The FDA 510(k) Clearance has been granted based on our premarket notification for indications for the Use of "elevating tissue temperature and temporary relief of muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or temporary relaxation of muscle".
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Medegen Receives FDA Clearance for MaxGuard(TM) Advanced Luer-Activated Device with Antimicrobial Technology
First Positive Displacement Needleless Connector with Antimicrobial Technology
Ontario, Calif., January 8, 2009 - (HSMN NewsFeed) — Medegen, a leading innovator in infusion therapy products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new MaxGuard(TM) Advanced Luer Activated Device featuring Agion® Antimicrobial Technology. MaxGuard is the first positive displacement needleless connector featuring impregnation of the antimicrobial additive into each of the components of the device. Laboratory testing has demonstrated this new antimicrobial device exhibits a kill rate of greater than 99.99 percent representing a 4+ log reduction on infection-causing organisms predominantly responsible for catheter related bloodstream infections.
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Ontario, Calif., January 8, 2009 - (HSMN NewsFeed) — Medegen, a leading innovator in infusion therapy products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new MaxGuard(TM) Advanced Luer Activated Device featuring Agion® Antimicrobial Technology. MaxGuard is the first positive displacement needleless connector featuring impregnation of the antimicrobial additive into each of the components of the device. Laboratory testing has demonstrated this new antimicrobial device exhibits a kill rate of greater than 99.99 percent representing a 4+ log reduction on infection-causing organisms predominantly responsible for catheter related bloodstream infections.
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Covidien Receives FDA Clearance to Market SILS(TM) Port Multiple Instrument Access Port
New Device Will Enable SILS(TM) Procedures
NORTH HAVEN, Conn., Jan. 8, 2009--(HSMN NewsFeed)--Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, today announced that its Surgical Devices business unit has received 510(k) clearance from the U.S. Food and Drug Administration to market the Covidien SILS(TM) Port Multiple Instrument Access Port for laparoscopic surgeries through a single incision.
The SILS(TM) Port is a single, flexible port that can be fitted through a small incision in the umbilicus which results in a single "hidden scar," a cosmetic advance over the multiple visible scars associated with standard multi-port laparoscopy. The port has the capacity for up to three laparoscopic instruments.
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NORTH HAVEN, Conn., Jan. 8, 2009--(HSMN NewsFeed)--Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, today announced that its Surgical Devices business unit has received 510(k) clearance from the U.S. Food and Drug Administration to market the Covidien SILS(TM) Port Multiple Instrument Access Port for laparoscopic surgeries through a single incision.
The SILS(TM) Port is a single, flexible port that can be fitted through a small incision in the umbilicus which results in a single "hidden scar," a cosmetic advance over the multiple visible scars associated with standard multi-port laparoscopy. The port has the capacity for up to three laparoscopic instruments.
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Integra LifeSciences Launches a Series of PEEK-Optima(R) Interbody Spinal Implants
PLAINSBORO, N.J., Jan. 9, 2009 -- (HSMN NewsFeed) -- Integra LifeSciences Holdings Corporation (NasdaqGS:IART ) announced today the launch of a series of intervertebral body fusion devices (IBD), the Vu e-POD(TM) and Vu L-POD(TM) through the newly formed Integra Spine.
The Vu e-POD and Vu L-POD received clearance from the United States Food and Drug Administration (FDA) to be marketed as a spinal IBD. Prior to receiving the IBD status, the devices were cleared by the FDA as spinal vertebral body replacement devices (VBR).The dual classification of the Vu e-POD and the Vu L-POD gives the surgeon a broader range of usages. As an IBD, they are used as an adjunct to fusion in patients with degenerative disc disease at one or two contiguous levels (L2-S1). As a VBR, they may be used to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (T1-L5).
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The Vu e-POD and Vu L-POD received clearance from the United States Food and Drug Administration (FDA) to be marketed as a spinal IBD. Prior to receiving the IBD status, the devices were cleared by the FDA as spinal vertebral body replacement devices (VBR).The dual classification of the Vu e-POD and the Vu L-POD gives the surgeon a broader range of usages. As an IBD, they are used as an adjunct to fusion in patients with degenerative disc disease at one or two contiguous levels (L2-S1). As a VBR, they may be used to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (T1-L5).
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Integra LifeSciences Announces Acquisition of Omni-Tract Surgical
PLAINSBORO, N.J., Jan. 9, 2009 -- (HSMN NewsFeed) -- Integra LifeSciences Holdings Corporation (NasdaqGS:IART ) announced today that it has acquired Minnesota Scientific, Inc. (d/b/a Omni-Tract Surgical).
Omni-Tract Surgical, based in St. Paul, MN, is a global leader in the development and manufacture of table mounted retractors. Omni-Tract markets and sells these systems for use in vascular, bariatric, general, urologic, orthopedic, spine, pediatric, and laparoscopic surgery. Integra expects to maintain Omni-Tract's operations in Minnesota and will integrate Omni-Tract's product lines into its combined offering of JARIT(R), Padgett(TM), R&B Redmond(TM), and Luxtec(R) lines of surgical instruments and illumination systems sold by the Integra Surgical sales team.
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Omni-Tract Surgical, based in St. Paul, MN, is a global leader in the development and manufacture of table mounted retractors. Omni-Tract markets and sells these systems for use in vascular, bariatric, general, urologic, orthopedic, spine, pediatric, and laparoscopic surgery. Integra expects to maintain Omni-Tract's operations in Minnesota and will integrate Omni-Tract's product lines into its combined offering of JARIT(R), Padgett(TM), R&B Redmond(TM), and Luxtec(R) lines of surgical instruments and illumination systems sold by the Integra Surgical sales team.
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Enocare - Galil Merger
Only months after Healthtronics withdrew its offer to acquire Endocare for $2.28 per share, Endocare and privately held Galil Medical have agreed to merge. The combined company will be focused on the development of cryoablation technologies, a minimally invasive method to freeze and destroy cancerous tumors.
read more >> http://www.onemedplace.com/blog/archives/1018
read more >> http://www.onemedplace.com/blog/archives/1018
Luminetx® Ends 2008 with Significant Global Growth
Luminetx® Corp. announced today it has completed 2008 with significant growth. According to company officials, global sales growth of Luminetx's signature product, the VeinViewer®, is being fueled by national penetration of the acute health care marketplace as well as a fast-growing international presence. In 2008, year-over-year unit sales saw an increase of 77 percent above that of 2007.
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VeinViewer sales now have occurred on every major continent. Domestically, several key achievements were noted. Multiple-unit sales increased steadily with clients recognizing VeinViewer as an institution-wide solution for reducing costs, helping reduce the potential for infection and greatly improving patient satisfaction scores. Representation in key top United States luminary institutions (as tracked by U.S. News and World Report rankings of the top 30 hospitals in the areas of cancer, heart conditions and pediatrics) climbed with more than 20 such institutions now carrying the VeinViewer.
full article >> http://www.pr-inside.com/luminetx-ends-2008-with-significant-global-r998001.htm
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VeinViewer sales now have occurred on every major continent. Domestically, several key achievements were noted. Multiple-unit sales increased steadily with clients recognizing VeinViewer as an institution-wide solution for reducing costs, helping reduce the potential for infection and greatly improving patient satisfaction scores. Representation in key top United States luminary institutions (as tracked by U.S. News and World Report rankings of the top 30 hospitals in the areas of cancer, heart conditions and pediatrics) climbed with more than 20 such institutions now carrying the VeinViewer.
full article >> http://www.pr-inside.com/luminetx-ends-2008-with-significant-global-r998001.htm
Rhode Island Hospital first in US to treat kidney tumor with new device using electrical pulses
PROVIDENCE, RI – On Thursday, January 8, Rhode Island Hospital treated an inoperable kidney tumor using a new technology known as NanoKnife. Damian Dupuy, MD, director of ablation services at Rhode Island Hospital and a national pioneer in ablation treatment, performed the procedure -- the first time it has been used on a kidney tumor in the United States.
NanoKnife is an image-guided device that uses "irreversible electroporation (IRE) technology" -- pulses of electricity that selectively destroy tumor cells while sparing nearby nerves, blood vessels and other delicate structures within the body. While considered a form of ablation, it uses electricity rather than heat like other ablation techniques such as cryo-ablation, radiofrequency and microwave ablation.
full article >> http://www.eurekalert.org/pub_releases/2009-01/l-rih010909.php
NanoKnife is an image-guided device that uses "irreversible electroporation (IRE) technology" -- pulses of electricity that selectively destroy tumor cells while sparing nearby nerves, blood vessels and other delicate structures within the body. While considered a form of ablation, it uses electricity rather than heat like other ablation techniques such as cryo-ablation, radiofrequency and microwave ablation.
full article >> http://www.eurekalert.org/pub_releases/2009-01/l-rih010909.php