ev3 Inc. Announces First Patient Enrollments in DEFINITIVE LE Post-Market Study

Largest Study to Date Will Evaluate SilverHawk Plaque Excision System for Treatment of Lower Extremity Peripheral Arterial Disease

PLYMOUTH, Minn., April 30 /PRNewswire/ -- ev3 Inc. (Nasdaq: EVVV) today announced that the first patients were recently enrolled in the DEFINITIVE LE post-market study. DEFINITIVE LE is a prospective, multi-center, single-arm study to evaluate the intermediate and long-term effectiveness of stand-alone SilverHawk(R) Plaque Excision therapy for endovascular treatment of lower extremity peripheral arterial disease (PAD). Stuart Harlin, M.D., of Sacred Heart Hospital in Pensacola, Florida and Prakash Makam, M.D., of Community Hospital in Munster, Indiana enrolled the first two patients.

To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/ev3/38145/

press release >> http://news.prnewswire.com/ViewContent.aspx?ACCT=109&STORY=/www/story/04-30-2009/0005016207&EDATE=

FDA has Granted HUD (Humanitarian Use Device) Designation to ITGI's Pericardium Covered Stents, Over and Under(R) and Aneugraft(R)

OR AKIVA, Israel, April 28 (HSMN NewsFeed) -- ITGI Medical, Ltd. (TASE: ITGI) a company engaged in research, development, manufacturing and marketing of heterologous tissue covered stents, announced that the US Food and Drug Administration (FDA) has granted HUD (Humanitarian Use Device) designation to Over and Under(R) and Aneugraft(R) Pericardium Covered Stents for treatment of perforations and dissections of native coronary arteries and Saphenous Vein Grafts.

This is the first step towards obtaining marketing approval.Over and Under(R) and AneuGraft(R) are stents 100% covered with a heterologous tissue, designed to set a barrier between the coronary blood vessel wall and its lumen. Stents are commercially available in Europe, Israel and Latin America for treatment of Saphenous Vein Graft stenosis, aneurysms and for emergency situations such as perforations.

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Gore Announces Availability of Larger Diameter, Small Profile GORE EXCLUDER AAA Endoprosthesis

Minimally Invasive Treatment Now Available to Broader Patient Population

FLAGSTAFF, Ariz.--(HSMN NewsFeed)--W. L. Gore & Associates (Gore) today announced the May 4, 2009 availability of a 31 mm diameter version of the GORE EXCLUDER(R) AAA Endoprosthesis. The device provides physicians with a safe and effective endovascular option to treat abdominal aortic aneurysms (AAAs) in patients with aortic inner neck diameters up to 29 mm. Other important enhancements include a flat-top design that enables greater production efficiency, an additional pair of proximal anchors to help ensure excellent fixation, and a lengthening of the trunk from 7 to 8 cm to accommodate larger anatomies.

More than 87,000 GORE EXCLUDER Devices have been implanted in patients worldwide, making it a widely accepted, minimally invasive treatment option for individuals with AAA. In March 2009, the US Food and Drug Administration (FDA) approved the 31 mm diameter version. It has been available outside of the US since 2004 and has been implanted in more than 3,300 patients.

Full article >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027920

Study Finds Cook Medical Resonance Metallic Ureteral Stent Provides 43 Percent Cost Savings

Presentation at 2009 AUA Conference Highlights Success of Stent in Cost-Effectively Treating Benign Ureteral Obstruction

BLOOMINGTON, Ind.--(HSMN NewsFeed)--The results of a 16-month clinical study showing that the Cook Medical Resonance Metallic Ureteral Stent could remain in a patient for up to 12 months; generating a 43 percent cost savings in treating benign ureteral obstruction, will be presented by Dr. Thomas M. Turk, a member of the study’s investigative team, during a press conference at the 2009 AUA Conference in Chicago on April 27. These results are compared to alternative polymer stent treatment methods which may require more frequent stent changes throughout the year.

The study, conducted by Hector L. Lopez- Huertas, M.D.; Anthony J. Polcari, M.D.; Alex Acosta-Miranda, M.D. and Dr. Turk at Loyola University Health System, evaluated the safety, efficacy and cost of two stent options for the management of benign ureteral obstruction: polymer or metallic stents. The study found the annual costs associated with the repeated stent changes required in patients with polymer stents were approximately $23,999 as compared to patients with a metallic stent that can remain in the patient for up to 12 months, costing approximately $13,605. Therefore, the Cook Resonance Metallic Ureteral Stent was associated with an average cost savings of $10,394, representing the 43 percent reduction per patient per year.

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First Ever Prospective Fracture Study in Prostate Cancer Patients on ADT Reveals These Men Are at High Risk for Skeletal Fractures

Data from GTx’s Phase III clinical trial evaluating toremifene 80 mg for the prevention of fractures in men with prostate cancer on androgen deprivation therapy presented at 2009 Annual Meeting of the American Urological Association

CHICAGO--(HSMN NewsFeed)--GTx, Inc. (Nasdaq: GTXI ) announced today that in a recent Phase III clinical trial of advanced prostate cancer patients being treated with androgen deprivation therapy (ADT), nearly one in four placebo group subjects developed bone fractures or critical bone loss (>7% loss) within two years. This analysis of placebo group data from the Phase III clinical trial evaluating toremifene 80 mg for the prevention of bone fractures in men with prostate cancer on ADT was presented yesterday in an oral presentation at the 2009 Annual Meeting of the American Urological Association in Chicago.

An analysis of placebo group subjects from the clinical trial demonstrates the risk of fracture for men with prostate cancer on ADT. During the two year trial, 9.9% of these men had a nontraumatic fracture (morphometric vertebral fracture or clinical fragility fracture), and nearly one in four, 23.9%, experienced either a nontraumatic fracture or greater than 7% bone loss, a predetermined level of bone loss at which men were considered to be at high risk for fracture and were removed from the study for safety reasons. These data are from the modified intent to treat population: subjects who had a minimum of one dose of study drug or placebo and at least one on study radiograph, n=970.

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Varian Medical Systems to Exhibit Full Spectrum of Prostate Cancer Treatment Technologies at the American Urological Association Meeting in Chicago

Company will showcase technologies for brachytherapy, intensity-modulated radiotherapy (IMRT), RapidArc(TM) radiotherapy, and stereotactic body radiotherapy (SBRT)

PALO ALTO, Calif., April 24 (HSMN NewsFeed) -- Varian Medical Systems (NYSE: VAR ) will showcase the company's full spectrum of prostate cancer treatment technologies at the upcoming American Urological Association (AUA) Meeting at McCormick Place in Chicago from April 25-30.

"Varian offers state-of-the-art technology for all five of the commonly-used radiotherapy approaches to treating prostate cancer," said Calvin Huntzinger, MS, senior director, Varian Surgical Sciences. "At the AUA meeting, we'll be exhibiting our latest solutions for high-dose-rate brachytherapy, planning for low-dose brachytherapy with permanent seed implants, 3-D conformal radiotherapy, intensity-modulated radiotherapy (IMRT), and stereotactic body radiotherapy (SBRT)." Each is a different approach to targeting prostate tumors with radiation.

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Cardiovascular Systems Expands Product Portfolio Company to Sell Invatec Balloon Catheters in the United States

ST. PAUL, Minn.--(BUSINESS WIRE)-- Cardiovascular Systems, Inc. (CSI) (Nasdaq:CSII), a medical device company developing and commercializing innovative interventional treatment systems for vascular disease, has expanded its product portfolio by signing an agreement with Invatec, a comprehensive provider of interventional products, to market Invatec’s PTA balloon catheter line in the United States. CSI is also launching the newest addition to its Viper line of supplemental products, the ViperSheath™ Introducer Sheath.

CSI’s flagship product is the Diamondback 360o™ Orbital Atherectomy System, a minimally invasive catheter system for treating peripheral arterial disease (PAD). Between 8 and 12 million Americans suffer from PAD, which is caused by the accumulation of plaque in leg or foot arteries, reducing blood flow. Symptoms include leg pain when walking or at rest, and PAD can lead to tissue loss and eventually limb amputation. The Diamondback 360o is highly effective in removing plaque and restoring blood flow in vessels both below and above the knee. In some cases, balloon angioplasty may also be used to achieve the desired vessel diameter after removing plaque with the Diamondback 360o.

Full text >> http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&newsId=20090408005258&newsLang=en

NMT Medical Receives PMA Approval for STARFlex as a Ventricular Septal Defect Repair Implant

BOSTON--(HSMN NewsFeed)--NMT Medical, Inc. (NASDAQ: NMTI ), an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures, today announced that it received Pre-Market Approval (PMA) from the U.S. Food and Drug Administration (FDA) enabling commercial sale of the Company’s STARFlex® cardiac septal repair implant in the United States for patients with ventricular septal defects (VSD). The STARFlex® implant can be placed in the heart to close the VSD using a catheter during a minimally invasive procedure, avoiding the need for the alternative treatment of open-heart surgery, which is considered a high-risk, invasive procedure.

Commenting on the FDA approval, Frank Martin, NMT’s President and Chief Executive Officer said, “The approval of STARFlex® for VSD is welcome news for NMT and our customers, along with their patients, as we can now offer this next generation implant. STARFlex® will replace our CardioSEAL® implant, which had previously received FDA approval for VSD treatment. STARFlex® features the addition of a unique self-centering mechanism, which accommodates easier implantation as well as the treatment of larger defects.”

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EDAP Announces Association of Italian Urologists Recommends HIFU as a Standard of Care for Prostate Cancer Treatment

LYON, France, April 8, 2009 -- (HSMN NewsFeed) -- EDAP TMS SA (NasdaqGM:EDAP ), the global leader in therapeutic ultrasound, announced today that the Association of Italian Urologists (AURO) has recommended High Intensity Focused Ultrasound (HIFU) as a standard of care for the treatment of prostate cancer as part of the Association's new guidelines on prostate cancer diagnosis and therapy.

The recommendation and updated guidelines on the use of HIFU for prostate cancer are based on the significant number of HIFU patients treated in Europe to date and on a comprehensive review of the current literature highlighting the positive clinical outcomes and acceptable follow-up.

Full article >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027769

Core Essence Receives FDA Approval for SECURUS(TM), an Innovative Knotless Suture Anchor System

YARDLEY, Pa., April 8 (HSMN NewsFeed) -- Core Essence Orthopaedics, Inc., a medical device company focused on soft tissue and skeletal repair of the extremities, today announced that it has received 510(k) regulatory approval from the Food and Drug Administration (FDA) for SECURUS(TM), a novel knotless suture anchor system used in minimally invasive, arthroscopic surgery. SECURUS provides increased flexibility, simplicity, and ease for surgeons seeking to employ minimally invasive techniques in the surgical treatment of rotator cuff repair.

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Medtronic Initiates Global Abdominal Aortic Aneurysm Study

ENGAGE Will Enroll 1,200 Patients At Up To 80 Sites Worldwide To Evaluate “Real-World” Performance of Endurant Stent Graft

MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE: MDT ), today announced the start of ENGAGE¹, the largest ever study of its kind, which will evaluate the performance of the Endurant stent graft, an implantable medical device designed to provide an advanced minimally-invasive alternative to open surgical repair of abdominal aortic aneurysms.

“ENGAGE seeks to involve more patients, at more sites and in more countries than any previous study of its kind,” according to Dr. Robert Fitridge of The Queen Elizabeth Hospital in Adelaide, Australia, one of the study’s seven executive committee members. “The data this multicenter international study collects on the Endurant stent graft will help physicians worldwide determine how best to treat abdominal aortic aneurysms in the real-world setting of standard clinical practice.”

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HydroCision Announces 40,000th Procedure Using Its Novel Cutting-with-Water Fluidjet Technology

BILLERICA, Mass.--(HSMN NewsFeed)--HydroCision Inc. (www.hydrocision.com) announced today that its novel cutting-with-water fluidjet technology has been used in over 40,000 spinal, arthroscopic and wound debridement procedures—thus firmly establishing HydroSurgery as a major platform for Minimally Invasive Surgery (MIS). “The company has capitalized on the double digit growth of the minimally invasive surgical market,” states Doug Daniels, President and CEO of HydroCision. “A large driver of our procedural growth has been patients who seek out surgeons that perform minimally invasive procedures. This has led to rapid adoption of these new and evolving techniques, for example, in back surgery by a growing number of neurosurgeons, orthopedic surgeons and interventional pain physicians to treat their patients’ pain in a variety of back procedures, including fusion and discectomy.”

The Company’s family of fluidjet products empowers surgeons to simultaneously cut, ablate, and remove hard and soft tissue quickly, safely, and effectively— without the collateral thermal or mechanical trauma of other surgical modalities.

Full article >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027766

Encision Signs a Non-Exclusive Manufacturing, Supply and Licensing Agreement With Intuitive Surgical

BOULDER, CO--(HSMN NewsFeed)--Apr 8, 2009 -- Encision Inc. ("Encision") (OTC BB:ECIA.OB ), a medical device company owning patented surgical technology that is emerging as a standard of care in minimally-invasive surgery, is pleased to announce that it has entered into a non-exclusive manufacturing, supply and licensing agreement with Intuitive Surgical Inc. ("Intuitive Surgical") (NasdaqGS:ISRG ) for the purchase and use of Encision's patented AEM® technology with Intuitive Surgical's da Vinci® Surgical Systems. Encision's agreement with Intuitive Surgical will allow Encision access beyond conventional laparoscopy to the next generation of minimally invasive surgery.

"We are excited about partnering with Intuitive Surgical, the world's leader in surgical robotics," stated Jack Serino, President and CEO of Encision Inc. "Prior to the agreement, Encision was focused on conventional laparoscopic surgery. Now, we can expand our technology into the rapidly growing market segment of laparoscopic robotic surgery."

Full article >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027761

Terason Announces Agreement with Premier Inc.

BURLINGTON, Mass.--(HSMN NewsFeed)--Terason, the innovator and leader in laptop ultrasound technology, today announced that it has signed a three-year agreement with Premier Purchasing Partners, L.P., the group purchasing unit of Premier Inc. The agreement, which is effective April 1, 2009, covers Terason’s complete product line of portable ultrasound imaging solutions, including the Terason 2000+™, Terason t3000™ and Terason Echo™ Ultrasound Systems.

“We are delighted to be a part of the Premier healthcare alliance through the awarding of this contract,” said Alice Chiang, Ph.D., Teratech CEO. “I am confident that Premier’s participating members will appreciate the exceptional image quality, portability and value that our ultrasound systems offer, just as we appreciate the distribution reach that results from our relationship with Premier.”

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FDA Approves Label Change for Non-Invasive Fibroid Treatment

Label Allows Doctors to Use ExAblate(R) to Treat up to 100% of Uterine Fibroid Volume

Label Change Based on Data Showing Greater Long-Term Symptom Reduction Following More Complete Fibroid Treatment

TIRAT CARMEL, Israel, April 7 (HSMN NewsFeed) -- InSightec Ltd. announced today that the U.S. Food and Drug Administration (FDA) approved a label change for the company's ExAblate® 2000 MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with non-hysteroscopically resectable uterine fibroids. Under the new labeling, the agency allows physicians to treat up to 100% of the fibroid compared to its previous restriction to only treat up to half the fibroid tissue.

"In allowing doctors to destroy the entire fibroid, we believe the FDA has demonstrated further confidence in the safety and efficacy of the non-invasive ExAblate system," said Haywood L. Brown, MD, Chair of Obstetrics and Gynecology/Maternal-Fetal Medicine at Duke Medicine in Durham, North Carolina.

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Bioject Medical Technologies Inc. (BJCT) Announces FDA Market Clearance for the Zetajet Needle-Free Injection Therapy System

PORTLAND, Ore.--(BUSINESS WIRE)--Bioject Medical Technologies Inc. (OTCBB:BJCT - News), a leading developer of needle-free injection therapy systems, today announced that the U.S. Food and Drug Administration (FDA) has granted market clearance for the Zetajet™ Needle-Free Injection Therapy System. Bioject’s new ZetajetTM system is the latest advance in needle-free delivery systems, offering a significant array of unique product features and patient benefits that can provide highly competitive differentiation to a wide variety of injectables market segments.

The Zetajet™ Needle-free Injection Therapy System is a compact, spring-powered, needle-free injection device. It is intended to deliver vaccines and injectable medications either subcutaneously or intramuscularly. The Zetajet™ uses jet force to propel a finely dispersed stream of injectable medication into the subcutaneous or intramuscular tissue without the use of a needle. The syringe assembly has a unique ”auto-disable” feature that prevents re-use of the syringe. The plunger is pre-assembled into the syringe and can be used for reconstitution and other pre-injection tasks.

Full article >> http://www.devicespace.com/news_story.aspx?NewsEntityId=133668

NHS National Innovation Centre Cites VNUS Closure(R) Procedure as Select Innovative Technology

Minimally Invasive Treatment for Varicose Veins to be showcased at National Health Service EXPO

SAN JOSE, Calif., April 3 /PRNewswire-FirstCall/ -- VNUS(R) Medical Technologies, Inc. (Nasdaq: VNUS), a worldwide leader in medical devices for the minimally invasive treatment of venous reflux disease, today announced that the UK NHS National Innovation Centre has identified the VNUS Closure(R) procedure as a select innovative technology that is bringing benefits to National Health Service (NHS) hospitals and patients. The VNUS Closure procedure is a minimally invasive treatment for patients suffering with symptomatic varicose veins and venous reflux, and has been demonstrated in numerous comparative studies to offer advantages over conventional vein stripping surgery. The technique will be showcased at the NHS EXPO Meeting on June 18-19, 2009.

Full text >> http://www.prnewswire.co.uk/cgi/news/release?id=253464

A revolutionary treatment for high blood pressure?

Washington, Apr 2 (PTI) Scientists have developed a "world-first" treatment to lower high blood pressure and the risk of sudden death, a finding they claim could revolutionise treatment options for hypertension around the world.

An international team, led by the Baker IDI Heart and Diabetes Institute in Australia, has developed the "catheter- based treatment" for life threatening high blood pressure and it also reduces the risk of stroke. According to them, the treatment involves inserting a catheter through the femoral artery of patients suffering from severe and resistant hypertension -- a dangerous form which doesn't always respond adequately to traditional medications.
The procedure, conducted under a local anaesthetic, uses radio energy frequency delivered via catheter to silence sympathetic nerves in renal artery -- the artery delivering blood supply to the kidneys, they said.

This one-off procedure, conducted on both kidneys, has the potential to substantially reduce the premature ill health and mortality attributed to high blood pressure, a university release said.

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GE Healthcare Introduces CARESCAPE Telemetry Platform for Wireless Patient Monitoring

WAUKESHA, Wis.--(BUSINESS WIRE)-- GE Healthcare introduced today its new CARESCAPE(TM) Telemetry platform, a wireless patient monitoring offering for hospitals. Built on GE CARESCAPE Enterprise Access(TM) and leveraging GE ApexPro(R) CH Telemetry, GE CARESCAPE telemetry enables hospitals to simultaneously leverage multiple telemetry frequencies and coordinate cell phone, Wi-Fi and other wireless technologies on one infrastructure.

The new CARESCAPE Telemetry offering consists of a seamless integration between ApexPro CH Transmitter, CARESCAPE Enterprise Access, CARESCAPE Telemetry Server, CARESCAPE T14 Transmitter and other components of an ApexPro Telemetry System. It provides dual-band capabilities enabling hospitals to simultaneously leverage the two protected frequency bands-- 600 MHz and 1.4 GHz -- in Wireless Medical Telemetry Service (WMTS) with a single, central telemetry system. Hospitals can monitor up to 438 patients while ensuring that critical patient data is sent securely without interference. Hospitals using GE Healthcare ApexPro CH telemetry transmitters have the flexibility to leverage the existing 600 MHz frequency band transmitters and expand into the 1.4 GHz frequency band with the CARESCAPE Telemetry T14 Transmitter on CARESCAPE Enterprise Access. Powered by MobileAccess and its Wire-it-Once infrastructure, CARESCAPE Enterprise Access seamlessly unites hospital wireless networks into one infrastructure, helping to eliminate coverage drop-out and downtime. As a hospital's wireless needs grow, this Wire-it-Once infrastructure can help reduce the costs and infection-control issues associated with installing new cables and antennas.

Press release >> http://www.tradingmarkets.com/.site/news/Stock%20News/2256611/

IQMax Delivers Healthcare Solutions to Blackberry Devices

Charlotte, NC (PRWEB) April 6, 2009 -- IQMax, Inc., a leading mobile healthcare solutions provider, is pleased to announce that its entire suite of healthcare solutions is available on Blackberry® devices including the Storm. With IQMax, physicians can dictate and document patient encounters, capture billable charges, and view patient information including lab results, alerts, allergies, medications, and pathology and radiology reports, at the point of care. IQMax provides physicians a continuity of care record for their patients across diverse care environments, whether they see patients at the hospital, clinic, or in a home healthcare environment. Now physicians can use the same device that they use to view email, manage their calendar and contacts, and access the internet, to stay connected to patient and clinical data anytime, anywhere, and anyplace.

Full article >> http://www.prweb.com/releases/2009/04/prweb2300464.htm

Edwards Lifesciences Launches New Software for FloTrac System to Enhance Performance in Patients With Sepsis

New Data Presented at ISICEM Demonstrate System Is Highly Accurate

ST-PREX, SWITZERLAND--(HSMN NewsFeed)--Apr 6, 2009 -- Edwards Lifesciences Corporation (NYSE:EW ), a global leader in hemodynamic monitoring, today announced the availability of third generation software (G3) for its minimally invasive FloTrac cardiac monitoring system that enhances the product's accuracy when used in patients with sepsis and other critical illnesses. The new software draws upon state-of-the-art analysis and a broader patient database to enable the FloTrac system to automatically and accurately adjust to the radical changes that occur in these patients. Sepsis is a common, life-threatening condition that results from the body's response to infection, with more than 18 million cases of severe sepsis reported worldwide each year.

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LDR Announces FDA Clearance of Its ROI-A ALIF Device

Innovative VerteBRIDGE(TM) Screwless Plating Technology Offers Simple Insertion and Stable Fixation

AUSTIN, Texas--(HSMN NewsFeed)--LDR, a total spine solution company, announced that it received FDA clearance on Feb. 2 to market its ROI-A(TM) implant as an anterior lumbar interbody fusion (ALIF) device. Previously cleared in April 2008 as a partial vertebral body replacement, the ROI-A(TM) system incorporates the innovative VerteBRIDGE(TM) screwless plating technology.

The ROI-A(TM) ALIF is a stand-alone implant system with zero profile, self-locking plates designed for initial and long-term stability. The surgical technique is a direct anterior approach, with the curved plates inserted along the sagittal plane thus requiring no additional exposure to the vertebral bodies.

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Cynosure Announces Presentation of Favorable Results from Post-Marketing Studies of Smartlipo MPX

Findings Demonstrate Statistically Significant Improvements in Skin Tightening and Tissue Shrinkage

Data to be Presented at 2009 American Society for Laser Medicine and Surgery Annual Conference

WESTFORD, Mass., April 2 (HSMN NewsFeed) -- Cynosure, Inc. (Nasdaq: CYNO ) today announced the presentation of positive efficacy data from two post-marketing studies that demonstrate the skin-tightening and tissue-shrinking effects of the Company's Smartlipo MPX(TM) laser lipolysis workstation. The studies are being presented at the 2009 American Society for Laser Medicine and Surgery (ASLMS) Annual Conference, which is taking place April 1-5 at the Gaylord National Resort & Convention Center near Washington, D.C.

A randomized, blinded study, conducted by Barry DiBernardo, M.D., Medical Director of New Jersey Plastic Surgery & MedNet Technologies, Inc., compared Smartlipo MPX workstation against liposuction for their ability to improve skin elasticity and tighten tissue. A total of 10 women received a single treatment with liposuction on one side of the abdomen and the dual-wavelength Smartlipo MPX on the other. Skin shrinkage was evaluated through photographic imaging and measurement of temporary ink markings. Skin tightening was evaluated with the use of an elasticity device. Measurements were taken at baseline and at one and three months post-treatment.

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NIMS Exer-Rest® Technology Linked to Reduced Brain Damage in Strokes

MIAMI--(BUSINESS WIRE)--Non-Invasive Monitoring Systems, Inc. [NIMS] (OTCBB:NIMU) announced today that the results of a laboratory investigation published in the April issue of the journal Neuroscience links the technology behind NIMS’ patented Exer-Rest® acceleration therapeutic platform to a reduction in brain damage for the major cause of stroke. In their report, “Whole-body periodic acceleration (pGz) reduces brain damage in a focal ischemia model,” Drs. Martinez-Murillo, Serrano, Fernandez and Martinez of CSIC and CIBIR, Madrid & Logroño, Spain concluded that whole body periodic acceleration (WBPA, pGz), the technology behind the Exer-Rest®, has potential to positively impact on the management of stroke, the third leading cause of death and the major cause of significant disability in adults living in the USA and Europe. They selected this treatment because it increases release of beneficial substances, such as nitric oxide, prostacyclin, prostaglandin E2, and adrenomedullin, from the inner lining of blood vessels into the circulation. These substances protect the brain from damage due to ischemia, i.e., cessation of blood flow to tissue. In their study, the investigators simulated occlusion of a brain blood vessel with clot, the cause of 85% of human strokes. In one group of rats, WBPA was administered for three hours immediately following the simulated stroke, while no treatment was provided to a control group. Magnetic resonance imaging (MRI) conducted 7 days after the simulated stroke revealed 82% less dead brain tissue in the WBPA-treated rats than in the untreated control group. In addition, biochemical markers of brain damage were significantly lower in the WBPA-treated animals.

Press release >> http://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20090401006091&newsLang=en

Chemists: Light-activated 'lock' can control blood clotting, drug delivery

GAINESVILLE, Fla. --- Scientists have shed new light -- literally -- on a possible way to starve cancer tumors or prevent side effects from a wide range of drugs.

A lock-like molecule designed by University of Florida chemistry researchers clasps or unclasps based on exposure to light. In laboratory tests, the chemists put the lock on an enzyme involved in blood clotting. They then exposed the enzyme to visible and ultraviolet light. The clasp opened and closed, clotting the blood or letting it flow.

The results suggest that the biological hardware could one day be used to prevent the formation of tiny blood vessels that feed tumors. The little lock could also be placed in drugs, giving doctors the ability to release them only on diseased cells, tissues or organs -- maximizing their efficacy while preventing side effects from damage to healthy tissue. Endoscopic lights inserted into the patient could unlock the drugs when desired -- or, the drugs could be activated by simply exposing the skin nearest the targets to near-infrared light, which penetrates the skin.

Full Article >> http://www.eurekalert.org/pub_releases/2009-03/uof-cl032509.php

UPDATE 1-US drops charges against orthopedic device makers

CHICAGO, March 30 (Reuters) - The U.S. Department of Justice said on Monday it dismissed criminal charges against four orthopedic device makers accused of making improper payments to surgeons who used their products.

The U.S. Attorney's Office in Newark, New Jersey, said it dismissed the complaints against Zimmer Holdings Inc (ZMH.N), Johnson & Johnson's (JNJ.N) DePuy unit, privately held Biomet Inc and Smith & Nephew Plc (SN.L) after the companies completed the terms of monitoring and deferred prosecution agreements with the government.
The complaints against the companies, filed in September 2007, alleged criminal violations of the federal anti-kickback statute.

Full article >> http://www.reuters.com/article/marketsNews/idINN3036047120090330?rpc=44

The MedTech Group Acquires TDC Medical

(4/1/2009) - The MedTech Group is pleased to announce the acquisition of TDC Medical. This new partnership combines 30 years of MedTech’s experience and success in plastic technology and medical product manufacturing with TDC’s reputation for excellence in medical product design, development and intellectual property creation. “The combination of The MedTech Group and TDC Medical brings forth unparalleled customer service, world-class product engineering and cutting edge manufacturing know-how and technology” said George Blank, MedTech’s President. He continued, “We intend to combine both companies’ passion for customer satisfaction to support the needs of emerging and established OEM customers in the medical marketplace.”

TDC Medical has design and development facilities in Marlborough, MA, Sunnyvale, CA and Boulder, CO. MedTech has manufacturing facilities in South Plainfield and Middlesex, NJ, West Haven, CT, Vega Baja, Puerto Rico and Heredia, Costa Rica.
The managements from both companies are excited about the merger due to shared similar ethical cultures, exclusive focus on the healthcare field and concentration on customer success

MicroTransponder Closes $2.2 Million Funding Round to Develop a Wireless Neurostimulation System for Chronic Pain

DALLAS--(BUSINESS WIRE)--March 31, 2009--MicroTransponder Inc., a privately held medical device company, announced today that it has closed a $2.2M Series A round of funding, which brings the total investment to over $4.85M in the last 11 months. MicroTransponder is developing a wireless neurostimulation system for the treatment of chronic pain and several other neurological indications. The minimally invasive system will provide relief from chronic pain without requiring an implanted battery or wires. Patients experiencing chronic pain will have an effective treatment using a significantly smaller and less invasive device. Over 30 Million Americans report severe chronic pain symptoms and the market for neurostimulation is currently $1.4 Billion annually. In addition to private funding, MicroTransponder has received an award from the Texas Emerging Technology Fund and three separate NIH SBIR grants, providing independent scientific validation of the technology.

Press release >> http://www.businesswire.com/portal/site/elpasotimes/?ndmViewId=news_view&newsId=20090331005372&newsLang=en

Navilyst Medical receives European patent for catheter slit valves for medical fluid infusion

PUB. NUMBER
EP2039388
Appl. Data
EP200819696A 20020408

NAVILYST MEDICAL INC
Haarala, Brett, T.
Driscoll, Arthur

TITLE
Catheter slit valves

ABSTRACT
Disclosed are improved catheter slit valves for medical fluid infusion and aspiration. The improved catheter slit valves use nonradial slits to address the problems found with conventional radial slit valves. The improved catheter slit valves also use radial and nonradial slits in combination with each other, protuberances, and caps to enhance the operation of the valves. Also disclosed are catheters with multiple slit valves, compound slit valves, multiple lumens, or combinations thereof. The catheters disclosed are made of biocompatible materials, such as polyurethanes, silicones, polyethylenes, nylons, polyesters, and polyester elastomers.

Doctors at Henry Ford Health System Treat Ovarian, Prostate, Lung, and Other Forms of Cancer Using Novalis Tx(TM) Platform for Image-Guided Radiosurge

Non-invasive treatments make it possible for some cancer patients to avoid the risks of surgery

DETROIT, April 1 (HSMN NewsFeed) -- Feeling robust and energetic, Marianne Henn, 68, was on her way to Florida to escape the Michigan cold. She had completed a course of stereotactic body radiotherapy (SBRT) for recurrent ovarian cancer just two days earlier, and her doctor, Kenneth Levin, MD, had no qualms about authorizing the trip.

"It thrilled me, that we could complete her treatment one day, and send her flying off to Florida two days later," said Dr. Levin, who is the director of radiation oncology at Henry Ford West Bloomfield Hospital, one of seven hospitals that comprise the Henry Ford Health System, one of the leading health care providers in the Midwest.Using Novalis Tx(TM) technologies from Varian Medical Systems and BrainLAB, Dr. Levin delivered a course of image-guided SBRT, a form of non-invasive treatment that uses precisely-shaped radiation beams to target tumors from outside the body.
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Abbott Initiates U.S. Study of Absolute Pro(TM) Peripheral Stent System for Iliac Artery Disease

MOBILITY trial showcases company's leadership in developing innovative endovascular treatment options

ABBOTT PARK, Ill., April 1 (HSMN NewsFeed) -- Abbott (NYSE: ABT) today announced the initiation of MOBILITY, a clinical trial studying the safety and efficacy of the Absolute Pro(TM) Peripheral Self-Expanding Stent System in patients with iliac artery disease. Iliac artery disease is a form of peripheral artery disease (PAD) that affects the lower extremities. The first patient was enrolled into the MOBILITY trial by John Campbell, M.D., assistant professor of surgery and medicine, West Virginia University School of Medicine, Charleston Division, at the Charleston Area Medical Center in Charleston, W. Va.

"Iliac artery occlusive disease has the potential not only to have a significant impact on a patient's ability to carry on daily activities, but it also can be an early sign of plaque buildup in other parts of the body," said Manish Mehta, M.D., M.P.H., FACS, director of Endovascular Services, The Vascular Institute for Health and Disease, Albany Medical Center in Albany, N.Y., and co-principal investigator of the MOBILITY trial. "The lower extremity discomfort and fatigue with walking and exercise caused by this debilitating disease can tremendously impact a patient's overall quality of life, making it critical to find effective treatments. Data from the MOBILITY trial will be an important addition to iliac stenting research."

Full article >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027709

New Clinical Study Shows Masimo PVI(TM) Accurately Predicts Fluid Responsiveness in the ICUFirst Study to Expand PVI Utility Beyond the OR

Presented at the 29th International Symposium on Intensive Care and Emergency Medicine in Brussels

IRVINE, Calif., March 31 (HSMN NewsFeed) -- Masimo (Nasdaq: MASI ), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low-Perfusion pulse oximetry, announced today that a new independent clinical study demonstrates Masimo PVI to be an "accurate index of fluid responsiveness" for critical care patients in the intensive care unit (ICU).(1) The study, presented at the 29th International Symposium on Intensive Care and Emergency Medicine on March 25, 2009, in Brussels, Belgium, is the first to show the potential value of Masimo PVI to predict fluid responsiveness beyond the operating room (OR) into the ICU.

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Stanford Study on CyberKnife Radiosurgery for Prostate Cancer Demonstrates 100 Percent PSA Response at 33 months

Prior Studies Demonstrate Frequency of Prostate Motion, Supporting Need for the CyberKnife System's Real-Time Tracking to Spare Surrounding Sensitive Structures

SUNNYVALE, Calif., March 31 (HSMN NewsFeed) -- Accuray Incorporated (Nasdaq: ARAY ), a global leader in the field of radiosurgery, announced today publication of the results from a prospective clinical study on CyberKnife radiosurgery for prostate cancer, which was published in the March 15, 2009 issue of the International Journal of Radiation Oncology*Biology*Physics - also known as the Red Journal.

The study, led by Christopher King, M.D. at the Stanford University School of Medicine, treated 41 low-risk prostate cancer patients using CyberKnife radiosurgery. Continual image guidance was used to verify target position throughout the procedure allowing the team to precisely deliver very high doses of radiation in five short treatments. At a median follow-up of 33 months, no patient experienced a PSA recurrence and early side effects were no worse than other prostate cancer therapies.

Full article >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027699

Invatec Introduces AMPHIRION DEEP Long Balloon to More Easily Access and Treat Arteries Below the Knee

Recent FDA 510(k) Clearance Extends Invatec’s Balloon Catheter Line

BETHLEHEM, Pa.--(HSMN NewsFeed)--Invatec, a comprehensive innovator of interventional products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Amphirion Deep 150 mm Long PTA Balloon and Tapered 210 mm Long PTA Balloon in the United States. The Amphirion Deep Long Balloons join the preexisting Amphirion Deep family of dedicated below the knee (BTK) PTA catheters, which are specifically designed to reach, access and treat arteries below the knee

Full text >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027696

Prostate Cancer Patients in US and Europe Receive Treatments Using Enhanced Seed Prostate Brachytherapy Software

Varian's VariSeed(TM) 8.0 Offers Advantages in Simplifying Dose Planning and Identifying Seed Positions, according to Clinicians

CHARLOTTESVILLE, Va., March 31 (HSMN NewsFeed) -- Prostate cancer patients have begun receiving brachytherapy using new treatment planning software that enables improvements in the precision and speed of the treatment process. VariSeed(TM) 8.0 from Varian Medical Systems (NYSE: VAR ) is an updated version of the company's market-leading treatment planning software for Low Dose Rate (LDR) brachytherapy in which radiation doses are delivered by implanting seeds within the prostate.

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St. Jude Medical and GE Healthcare Announce Worldwide Market Launch of Wireless Integrated FFR Solution

UPPSALA, Sweden & WAUKESHA, Wis. & ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) and GE Healthcare today announced the worldwide commercial launch of the first fully integrated wireless solution for the measurement of Fractional Flow The new FFR solution, seamlessly integrated into existing cathlab infrastructure, will enable physicians and cathlab staff immediate access to FFR measurement without time consuming setup.

The new FFR solution, seamlessly integrated into existing cathlab infrastructure, will enable physicians and cathlab staff immediate access to FFR measurement without time consuming setup.The solution is based on the PressureWire® Aeris technology and an FFR upgrade package available for the XT and XTi system configurations of GE’s Mac-Lab® hemodynamic recording system, a system used to record and display physiological parameters in the coronary cathlab. PressureWire Aeris was developed and marketed by Radi Medical Systems, which was acquired in December 2008 by St. Jude Medical and is now part of the Company’s Cardiovascular Division.

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Study Shows Stereotactic Biopsy System Delivers Greater Accuracy in Detecting Cancer and Planning for Targeted Prostate Cancer Therapies

ATLANTA, GA and MOBILE, AL--(HSMN NewsFeed)--Mar 27, 2009 -- Urologists convening this week at the Southeast Conference of the American Urological Association (AUA) in Mobile will deliver results from a study of a prostate biopsy targeting method that guides accurate and reproducible prostate biopsies. Additionally, the preliminary data shows that the stereotactic biopsy system, called TargetScan, may be used to guide delivery of targeted, focal prostate cancer therapies.

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SenoRx Announces CE Mark to Commercialize Contura(tm) MLB in Europe

IRVINE, Calif., March 26, 2009 -- (HSMN NewsFeed) -- SenoRx (NasdaqGM:SENO ) today announced that it has received the right to apply the CE Mark to its Contura(tm) MLB short-term breast radiation balloon catheter. The multi-lumen radiation balloon delivers radiation to the tissue surrounding a lumpectomy cavity following surgery for breast cancer. The CE Mark applies to both the original size Contura MLB, which is designed for lumpectomy cavities of 4 to 5 centimeters in diameter, as well as the more recently cleared, larger-size Contura Shape Select(r) MLB designed for cavities ranging from 4.5 to 6 centimeters. The CE Mark is required for sales in countries within the European Economic Community. SenoRx had previously announced the receipt of 510(k) clearance in the United States for the original Contura in May 2007 and for the larger-size Contura in July 2008.

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GE’s First Portable ECG, “Medical Texting,” Arrive in US

WAUWATOSA, Wis.--(BUSINESS WIRE)--March 13, 2009--Medical testing meets medical “texting” with the US Food and Drug Administration clearance of GE Healthcare’s latest ECG (electrocardiogram) solution, the portable MAC 800, based on cell phone technology. Targeting physician’s offices and the pharmaceutical industry, GE’s entry into the portable ECG market is as practical as it is innovative.

Originally developed and introduced in China, for China in 2008, the lightweight portable device combines the keypad of a phone with a full-size color display and world-class diagnostic software to help clinicians shape the future of healthcare in regions across the world.

Full text >> http://www.reuters.com/article/pressRelease/idUS111212+13-Mar-2009+BW20090313

Olympus Medical Systems in Collaboration with Medinol Ltd. Announces the Release of the X-Suit NIR(R), a Biliary Metallic Stent

Expanding the Business of EndoTherapy Devices Through the Metallic Stent Market in Europe, the US and Parts of Asia

HAMBURG, Germany--(HSMN NewsFeed)--Olympus Medical Systems Corporation, in collaboration with Medinol Ltd., announces the release of the X-Suit NIR(R), a biliary metallic stent featuring exceptional anatomic conformability. This device will launch in Europe and parts of Asia on March 27, 2009 followed by the US on April 24, 2009. In Japan and other territories the product will be launched after obtaining marketing approval from the regulatory authorities. The president of Olympus Medical Systems Corporation, Haruhito Morishima, declared: “I am pleased to announce that we will soon be launching a new metallic stent which is an essential component of endoscopic treatment for biliary duct lesions. This product is the fruit of years of groundwork in collaboration with an Israeli company, Medinol. The product offers both excellent radial force and flexibility, which are crucial requirements for the stents. We can confidently recommend this high-quality stent system to our customers.”

Press release >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027577

LUMEDX Launches New Interventional Radiology Software

IR Solution for Electronic Procedure Records, Billing and Inventory, and JCAHO Compliance

OAKLAND, Calif., March 19 (HSMN NewsFeed) -- LUMEDX Corporation, a leading provider of fully integrated medical imaging and information systems, introduces new software to collect interventional radiology procedural information at the point of care: http://www.lumedx.com/IR/

Delivering comprehensive data capture for both general and vascular procedures, the Interventional Radiology module automatically documents JCAHO and patient safety performance measures. This new solution is the first commercial software to offer sophisticated, integrated tools for this vital service line, and was designed to meet hospitals' clinical--and business--objectives.

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Harvard Study Favors Cayenne Medical's AperFix Technology for Reconstruction of Torn ACL

"Single-Tunnel, Double-Bundle" Technique Shown to More Closely Resemble Intact ACL than "Single-Bundle" Technique

BOSTON--(HSMN NewsFeed)--Cayenne Medical, Inc., a privately held sports medicine company based in Scottsdale, announced today that a new Harvard clinical study published in the American Journal of Sports Medicine (AJSM) found that Cayenne’s AperFix(R) System and "Single Tunnel, Double Bundle™" ACL reconstruction technique better resembles the natural, intact ACL when compared to the more common, "Single-Bundle" technique.

The study, titled "Biomechanical Comparison of Single-Tunnel, Double-Bundle and Single-Bundle Anterior Cruciate Ligament Reconstructions," appears in the current issue of AJSM and was authored by Hemanth R. Gadikota, MS, Jong Keun Seon, MD, Michal Kozanek, MD, Luke S. Oh, MD, Thomas J. Gill, MD, and Guoan Li, PhD, all from the Department of Orthopaedic Surgery at Massachusetts General Hospital and Harvard Medical School; and Kenneth D. Montgomery, MD, of Tri-County Orthopaedic & Sports Medicine in Morristown, New Jersey.

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Breast-Specific Gamma Imaging (BSGI) Can Reduce the Number of Unnecessary Breast Biopsies When Compared to MRI

Pivotal Study Presented at Interdisciplinary Breast Center Conference

NEWPORT NEWS, Va., March 18 (HSMN NewsFeed) -- Women that require additional diagnostic imaging after a questionable mammogram may be at risk for unnecessary biopsies when only magnetic resonance imaging (MRI) is offered, according to a new study presented at the 19th Annual National Interdisciplinary Breast Center Conference in Las Vegas.

"Our goal was to see if BSGI could be used to improve upon the specificity of MRI, and also reduce the number of biopsies. The study is important because with the addition of BSGI, we could eliminate the need for 50 percent of biopsies or possibly change a patient's decision to have more radical surgery," said Dr. Leora Lanzkowsky, Director of Women's Imaging, CHW - Nevada Imaging Centers in Las Vegas.

Full article >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027562

Flexible Stenting Solutions, Inc. Announces IDE Submission for FlexStent(R) Femoropopliteal Self Expanding Stent System

EATONTOWN, N.J.--(HSMN NewsFeed)--Flexible Stenting Solutions Inc. (“FSS”), a leading developer of next generation peripheral arterial stents has submitted an Investigational Device Exemption (IDE) application to the FDA for its FlexStent(R) Femoropopliteal SE Stent System for the treatment of peripheral artery disease in the superficial femoral and popliteal arteries. This next generation femoropopliteal stent and delivery system can significantly improve patient care in the high growth peripheral vascular segment.

While stent procedures have become widespread in the treatment of coronary arterial disease, their use in the more challenging peripheral vascular disease setting had been limited in the last several years by inadequate stent design. The fully connected flexible FlexStent(R) has coupled technology with clinical needs by providing a highly durable and fatigue resistant stent. The FlexStent(R) has superior radial stiffness, as well as excellent conformability to and mobility with the treated vessel. The delivery system provides simplicity, ease-of-use and accurate, uniform stent placement for the vascular interventionalist.

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Edwards Lifesciences Completes Enrollment in Non-Surgical Study Arm of U.S. Clinical Trial for Transcatheter Valve

IRVINE, CA--(HSMN NewsFeed)--Mar 17, 2009 -- Edwards Lifesciences Corporation (NYSE:EW ), the world leader in the science of heart valves, today announced completion of enrollment in the 350-patient non-surgical study arm of its U.S. pivotal trial -- known as the PARTNER Trial -- for the Edwards SAPIEN transcatheter aortic heart valve.

"Reaching this milestone is a significant achievement for the subset of patients suffering from severe aortic stenosis who can't tolerate conventional aortic valve replacement. Without a transcatheter heart valve, they have no definitive treatment options for addressing their valve disease," said Craig Smith, M.D., interim surgeon-in-chief and chief of cardiothoracic surgery at NewYork-Presbyterian Hospital/Columbia University Medical Center, the Calvin F. Barber Professor of Surgery at Columbia University College of Physicians and Surgeons, and co-principal investigator for the trial.

Full article >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027554

OrbusNeich Files Patent Infringement Lawsuit Against Boston Scientific

FT. LAUDERDALE, Fla. and HONG KONG, March 16 (HSMN NewsFeed) -- OrbusNeich Medical, Inc. ("Orbus" or the "Company"), a designer, developer, manufacturer and marketer of innovative medical devices for the treatment of vascular diseases, today announced that it has filed a lawsuit against Boston Scientific Corporation ("BSC"). The lawsuit, filed in the United States District Court for the Eastern District of Virginia, asserts claims against BSC for patent infringement, breach of contract and for misappropriation of trade secrets. The suit seeks unspecified monetary damages and injunctive relief in connection with its claims.

Orbus is the owner by assignment of all right, title, and interest in U.S. Patent No. 7,329,277 entitled "Stent Having Helical Elements" and U.S. Patent No. 6,821,292 entitled "Crimpable Intraluminal Endoprosthesis Having Helical Elements." In its complaint Orbus alleges, among other things, that BSC has infringed these two Orbus patents relating to its proprietary luminal stent technology.

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Cordis Corporation Announces Head-to-Head Randomized Clinical Trial Comparing the NEVO Sirolimus-Eluting Coronary Stent to the XIENCE Stent

BRIDGEWATER, N.J.--(HSMN NewsFeed)--Cordis Corporation, a worldwide leader in the field of interventional cardiology, announced plans today to launch a global, head-to-head, randomized clinical trial called NEVO II which will compare the NEVO(TM) Sirolimus-eluting Coronary Stent to the XIENCE V(TM) Everolimus-eluting Coronary Stent. Cordis Corporation and Conor Medsystems, LLC are sponsors of the study. NEVO(TM) is the first and only drug-eluting stent utilizing a unique reservoir (RES) technology, which Cordis acquired from Conor Medsystems, LLC in 2007, and incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. This revolutionary design allows drug delivery from a stent with a surface that is 75 percent bare metal upon insertion and becomes fully bare metal following drug delivery and polymer bioresorption in approximately three months.

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CytRx's Arimoclomol Demonstrates Statistically Significant Neurorestorative Results in a Preclinical Embolic Stroke Trial

Data Supports Previous Preclinical Results Indicating Improvement in Stroke Recovery Following Oral Arimoclomol Administration

LOS ANGELES--(HSMN NewsFeed)--CytRx Corporation (NASDAQ:CYTR ), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced data from an animal stroke trial indicating that treatment with its molecular chaperone amplifier drug candidate, arimoclomol, initiated at either six, 10, 24 or 48 hours post-stroke, demonstrated neurorestorative ability based on multiple behavioral tests measuring motor and sensory recovery.

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New Clinical Study Finds Masimo Rainbow SET(R) Pulse CO-Oximetry(TM) Accurate in the Noninvasive Monitoring of Fluid Status During Surgery

UCSF Researchers Presented Study Data Demonstrating the Unique Ability of Masimo PVI(TM) to Reflect Acute Changes in Intravascular Fluid Volume at the International Anesthesia Research Society 83rd Scientific Congress

IRVINE, Calif.,, March 16 (HSMN NewsFeed) -- Masimo (Nasdaq: MASI ), the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low-Perfusion pulse oximetry, today announce that a new clinical study, independently conducted by researchers from the University of California-San Francisco (UCSF), demonstrates that Masimo PVI accurately and reliably reflects acute changes in intravascular fluid volume (preload).(1) The study, presented at the International Anesthesia Research Society (IARS) 83rd Scientific Congress on March 14th in San Diego, Calif., affirms PVI as a highly predictive indicator of patient fluid status.

Assessing whether a patient needs fluid to increase their cardiac index (amount of blood the heart pumps each minute) is one of the biggest challenges anesthesiologists face during surgery. Although fluid administration is critical to optimizing patient status and enabling end organ preservation, unnecessary fluid administration is associated with increased morbidity and mortality(2) and traditional invasive measurements are only 50 to 60% accurate at predicting improvement in cardiac index after volume administration.(3) PVI--a new method for noninvasive and automatic assessment of fluid responsiveness--has been shown in multiple studies to predict fluid responsiveness in mechanically ventilated patients, helping clinicians to optimize fluid administration and improve patient outcomes.(4-6)

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Alsius Corporation Announces Agreement to Sell Assets to ZOLL Medical Corporation

IRVINE, Calif., Feb. 20 (HSMN NewsFeed) -. Alsius Corporation (Nasdaq: ALUS ) announced today that it has signed an agreement with a wholly- owned subsidiary of ZOLL Medical Corporation (Nasdaq: ZOLL ) under which Alsius will sell to ZOLL substantially all the assets constituting Alsius' intravascular temperature management device business for a purchase price of $12 million in cash. The assets to be acquired include the intellectual property relating to the business, other intangibles, inventories and fixed assets. The closing of the transaction is subject to customary closing conditions.

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Bovie Medical Corporation Reports Success with Seer Tissue Resection Device Sales and Marketing

MELVILLE, N.Y.--(HSMN NewsFeed)--Bovie Medical Corporation (the “Company”) (NYSE Alternext US: BVX), a manufacturer and marketer of electrosurgical products, today announced that the Company has completed numerous successful surgical procedures with its SEER tissue resection device in France, Italy, Belgium, Spain and in the United States. Sales of the product have commenced in both the U.S. and abroad.

The SEER utilizes RF energy and saline together with Bovie’s proprietary technology to create a distinct clinical effect that has been initially used in solid organ resection to cut tissue and limit blood loss while improving surgeon visibility and patient outcomes.

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Cardo Medical Announces Femur-First Versatility With Its Uni-Compartmental Knee System

LOS ANGELES, CA--(HSMN NewsFeed)--Feb 18, 2009 -- Cardo Medical (OTC BB:CDOM.OB ), a company engaged in the development of orthopedic medical devices, announces the femur-first versatility in surgical technique with its Uni-Compartmental Knee System. Uni-compartmental knee arthroplasty procedures are most commonly performed using tibial-first referencing surgical techniques; however the Cardo Medical Uni-Compartmental Knee system also provides surgeons with additional intra-operative versatility to easily adapt to femur-first surgical techniques. Dr. Andrew Yun, an orthopedic surgeon at St. John's Hospital in Santa Monica, CA, has performed numerous femur-first uni-compartmental arthroplasty procedures and commented, "I have been very satisfied with the ease of use and outcomes with this system. The Cardo engineering team has been incredible to work with, and I have enjoyed the responsiveness and quality of work which comes from this group." In addition, Dr. Jonathan Braslow, an orthopedic surgeon at JFK Memorial Hospital in Indio, CA, also stated, "The Cardo Align 360 instrumentation system eliminates the guesswork for the first cut, the system was easy and simple to use and creates a reproducible outcome each time." The Align 360 Uni-Compartmental Knee System, Cardo Medical's initial product release, has been used successfully since its introduction in January 2007. System enhancements for the femur-first approach include novel, unique femoral tibial alignment ("knee jack") instruments with dedicated alignment and resection guides.

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Power Medical Interventions Receives FDA 510(k) Marketing Clearance for i60RL Intelligent Surgical Instruments(tm)

LANGHORNE, Pa., Feb. 17, 2009 (GLOBE NEWSWIRE) -- Power Medical Interventions(r), Inc. (NasdaqGM:PMII - News), a leader in developing and commercializing Intelligent Surgical Instruments(tm), announced today that the U.S. Food and Drug Administration has cleared its 510(k) application for marketing its patented i60RL Intelligent Surgical Instrument. The i60RL Intelligent Surgical Instrument is the world's first reverse pivot linear cutter, designed to improve medical outcomes by providing surgeons with greater access to important anatomical sites that are currently difficult to reach. The i60RL will be available for applications throughout the digestive tract. The Company intends to launch the product in April 2009.

Full article >> http://www.devicespace.com/news_story.aspx?NewsEntityId=126503

Syneron(TM) Partners With the American Academy of Cosmetic Physicians (AAOCP) to Train LipoLite(TM) and Laser LipoSculpture Physicians

LipoLite Customers Receive Complimentary AAOCP Membership With PurchaseIRVINE, CA--(HSMN NewsFeed)--Feb 17, 2009 -- Syneron(TM) Medical Ltd. (NasdaqGS:ELOS ), an innovator in the development, marketing and sales of elos(TM) combined-energy medical aesthetic devices, today announces a partnership with the American Academy of Cosmetic Physicians (AAOCP) to support laser liposculpture courses for Syneron's LipoLite(TM) laser-assisted liposuction device. The AAOCP is an organization of physicians who have successfully integrated aesthetic procedures into their practice. The AAOCP is dedicated to enhanced clinical training and safety and the exchange of best practices and ideas.

As part of the partnership, the AAOCP will train new Syneron LipoLite physicians and refer physicians to LipoLite as a preferred laser-assisted liposuction device. Syneron will offer all LipoLite customers complimentary membership into the AAOCP and recommend AAOCP to physicians for training.

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Bard Receives FDA Approval for the LifeStent Vascular Stent

MURRAY HILL, N.J.--(HSMN NewsFeed)--C. R. Bard, Inc., (NYSE: BCR ) today announced that it has received Pre-Market Approval (PMA) from the United States Food and Drug Administration to market the LifeStent® FlexStar and FlexStar XL Vascular Stent Systems. The devices are approved for the treatment of occlusive disease in native superficial femoral arteries (SFA) and proximal popliteal arteries, and are marketed by the Bard Peripheral Vascular Division, located in Tempe, Arizona.

Two-year clinical data on the LifeStent® vascular stent demonstrated a freedom from target lesion revascularization rate of 78% vs. 42% (p<.0001) for percutaneous transluminal angioplasty alone. In addition, the device exhibited a low fracture rate of 3.8% at 18 months. Dr. Barry Katzen, M.D., founder and medical director of Baptist Cardiac & Vascular Institute and co-principal investigator of the LifeStent® RESILIENT trial, commented, “The long-term data recently presented are important because they demonstrate the sustained performance of the LifeStent® vascular stent. Of particular significance to clinicians and patients is the approval of the 170mm stent, the longest commercially available in the United States. Henceforth, long and diffuse lesions presenting in the SFA can be effectively treated with a single stent, which should help improve both clinical outcomes and procedural costs.”

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Cardinal Health Announces New Name for Spinoff Company

DUBLIN, Ohio, Feb. 16 (HSMN NewsFeed) -- Cardinal Health, a global provider of products and services that improve the safety and productivity of health care, has selected a name for the medical technology company that will be formed through the proposed spinoff of its Clinical and Medical Products businesses.

The new company will be named CareFusion®, reflecting a diverse blend of medical technologies the company will offer to improve the safety and quality of care. From infusion and medication safety technologies to respiratory equipment, automated medical supply dispensing and infection prevention offerings, CareFusion® will be the largest medical technology company with a singular focus on patient safety. The new company expects to trade on the New York Stock Exchange under the ticker symbol CFN.

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Aesthetic Sciences Announces European Clearance to Market Breakthrough Dermal Filler Delivery System

MENLO PARK, Calif.--(BUSINESS WIRE)--February 12, 2009--Aesthetic Sciences announced today that it has received the CE Mark for its breakthrough dermal filler delivery system, the Smartfil™ Power-assisted Injection System. The CE Mark provides clearance for sales throughout Europe. The Smartfil™ system is the first powered device approved to be used with dermal fillers and the first product in the new category of power-assisted injection systems. In clinical studies with 100 patients and 25 doctors, this system demonstrated unique benefits to the injection process.
The company believes the controlled and smooth injection flow provided by this novel system will be well received by doctors and patients. Much of the clinical work was performed by Dr. Stacy Smith of Therapeutics, Inc. along with doctors from the United States, the United Kingdom and Germany. Dr. Smith observed, “Based on use in a controlled clinical setting, doctors noted improved precision in the placement of fillers, less fatigue and overall improved quality of correction when using the Smartfil™ system. Additionally, patients noted less pain and bruising with this system as compared to manual injections.”

Press release >> http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20090212005830&newsLang=en

Sensiotec Announces FDA 510(k) Class II Clearance for the World's First UWB Healthcare Unbound, Wireless, Non-Contact, Vital Signs Monitor

Device Monitors Heart and Respiration Rates, Bed Occupancy and Movement, Without Using Electrodes, Wires or Other Attachments that Cause Bruising, Skin Injury or Discomfort

ATLANTA, Feb. 11 (HSMN NewsFeed) -- Sensiotec Inc. announces FDA 510(k) Class II clearance for the world's first ultra-wideband (UWB) non-contact, continuous monitor for heart and respiration rates, bed occupancy and movement. Under the brand name Preventa(TM), Sensiotec will market and sell the medical device in the US and Canada under an exclusive worldwide license with its affiliate, Wireless 2000. Wireless 2000 received the sign off from the FDA's Division of Cardiovascular Devices.

Preventa(TM) is the first medical device to harness the potential of UWB, an emerging wireless communications standard and former classified military technology, creating a wireless vital signs monitor. In 2002, the FCC authorized the use of UWB for the development of new imaging systems to "see" inside the human body. Sensiotec CEO Robert Arkin states, "We're excited by the opportunity with Preventa(TM) to make a difference in people's lives through improved disease management while also addressing society's need to help contain runaway healthcare costs."

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Biomarker Combination and Risk of Ovarian Malignancy Algorithm (Roma(TM)) Demonstrates Accuracy in Detecting Ovarian Cancer

Data Presented at the Society of Gynecologic Oncologists' 40th Annual Meeting on Women's Cancer Proves Superiority of HE4, CA125 and ROMA(TM) Over Existing Tools

MALVERN, Pa., Feb. 11 (HSMN NewsFeed) -- New data presented on Saturday during the plenary session at the Society of Gynecologic Oncologists' 40th Annual Meeting on Women's Cancer demonstrated the accuracy of the HE4 test - in combination with CA125 blood test results and the Risk of Ovarian Malignancy Algorithm (ROMA(TM)) - in assessing the risk of ovarian cancer in women who will undergo surgery to remove a pelvic mass compared to the Risk of Malignancy Index (RMI). The data show that ROMA achieved greater sensitivity in distinguishing a benign mass from epithelial ovarian cancer (EOC) in premenopausal and postmenopausal women, and more accurately assigned patients with EOC to a high-risk group compared with RMI.

These results have important implications for the more than 280,000 American women who will be diagnosed with a pelvic mass over the course of a year. By combining the biomarkers HE4 and CA125 along with ROMA, the Fujirebio Diagnostics test appears to be more sensitive than the traditional RMI, which utilizes CA125 and imaging as well as menopausal status to evaluate the risk of ovarian cancer. CA125 is the current gold standard for monitoring patients diagnosed with ovarian cancer, but is less sensitive when used as a risk stratification tool, especially in premenopausal women, as elevated CA125 blood levels can result from non-cancerous conditions.

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Study Demonstrates Restylane(R) Effect Lasted 18 Months in 97% of Patients With One Repeat Injection

SCOTTSDALE, Ariz., Feb. 10 (HSMN NewsFeed) -- Recent clinical data show that Restylane(R) lasted 18 months in 97% of patients with one repeat injection. Restylane(R) is the only HA filler with an 18-month FDA-approved duration claim.

These data were generated in a controlled, randomized, evaluator-blinded study that assessed the safety and effectiveness of two different retreatment schedules, 4.5 months or 9 months, after initial treatment of nasolabial folds (NLF). Patients were evaluated using the Wrinkle Severity Rating Scale (WSRS), a five-point scale to measure visual severity of wrinkles where five is the most severe rating (extreme). 92% of patients were naive to dermal fillers so had no residual effects from earlier treatment.

Full article >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027206

Physicians Continue to Limit Sales Rep Access

More Than 38 Percent of Doctors Require Appointments, According to SK&A's Survey of U.S. Medical Practices

IRVINE, CA--(HSMN NewsFeed)--Feb 10, 2009 -- SK&A, a leading provider of healthcare information solutions and research, today announced the latest results of its ongoing survey of U.S. medical practices to determine their policies for allowing healthcare industry sales representatives access to physicians and other prescribers. In another setback to field sales groups, SK&A identified a clear trend that more physicians are requiring appointments from reps or limiting their access altogether.

Between June and December 2008, the percentage of physicians who require appointments advanced from 31.4 percent to 38.5 percent. Also, the percentage of physicians who forbid sales rep access altogether rose from 22.3 percent to 23.6 percent. These findings are based on telephone interviews with 227,000 medical practices representing 640,400 doctors. SK&A surveys its Office-Based Physicians database every six months from its Research Center in Irvine, Calif.

Full article >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027205

B. Braun Wins Premier Contract for Full Line of Dialysis Products

BETHLEHEM, Pa., Feb. 10 (HSMN NewsFeed) -- B. Braun Medical Inc. (B. Braun), a global leader in infusion therapy and pain management as well as a pioneer in passive safety devices and PVC-free and DEHP-free products, announced today that it has been awarded a three-year contract by Premier Purchasing Partners, LP for both hemodialysis and continuous renal replacement therapy (CRRT) dialysis products.

The contract, which became effective on November 1, 2008, offers Premier members - a network of approximately 2,100 hospitals and 53,000 healthcare facilities - access to contracted pricing on B. Braun's full line of dialysis products.

Full text >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027203

Guided Therapeutics, Inc. Reports Preliminary Findings from FDA Pivotal Clinical Trial

Non-invasive technology finds disease missed by Pap test

ATLANTA--(HSMN NewsFeed)--Guided Therapeutics, Inc. (GT) (Pink Sheets: GTHP ) today announced that its LightTouch™ non-invasive cervical cancer detection technology properly identified cervical disease missed by Pap tests and conventional pathology in a multi-site Food and Drug Administration (FDA) pivotal clinical trial. Based on the outcome of the study, GT plans to submit the trial results to the FDA as part of the Premarket Approval (PMA) application for the LightTouch.

“We are very pleased that the results of the study indicate that the LightTouch is capable of discovering disease that may be missed by conventional cervical disease detection,” said Mark L. Faupel, Ph.D., GT President and CEO at the Southeastern Medical Device Association annual conference in Atlanta. “Based on the study results, we believe that our technology also demonstrates the capability to detect cervical disease early, when it is most effectively treated.”

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FDA Approves Clinical Studies of a Novel Anti-Cancer Drug Developed by Italian Researchers

Nerviano Medical Sciences (NMS): Green Light From the FDA for the CDC7 Inhibitor

NERVIANO, Italy, February 10 (HSMN NewsFeed) -- Nerviano Medical Sciences (NMS) has secured Food and Drug Administration (FDA) approval to conduct for the first time clinical trials of a novel antitumoral agent. The drug blocks Cdc7, a protein that is responsible for the uncontrolled proliferation of cancer cells. The preclinical data, recently published on the prestigious journal Nature Chemical Biology ( http://www.nature.com/nchembio/journal/v4/n6/full/nchembio.90.html), demonstrate that inhibition of Cdc7 induces tumor cell death and blocks the growth of various types of cancer in experimental animal models.

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GORE Flow Reversal System Cleared by FDA

Breakthrough System Provides Neuroprotection During Carotid Artery Stenting by Reversing Blood Flow at the Treatment Site and Continuously Directing Emboli Away from the Brain

FLAGSTAFF, Ariz.--(HSMN NewsFeed)--W. L. Gore & Associates (Gore) today announced at the International Congress on Endovascular Interventions XXII the US Food and Drug Administration (FDA) has given the company 510(k) clearance to market the GORE Flow Reversal System. This new technology minimizes the risk of emboli reaching the brain during critical stages of carotid artery stenting (CAS), expanding treatment options for broad patient populations with carotid artery disease.

One of the major challenges associated with CAS is the risk of peri-procedural embolic events that could cause a stroke. The GORE Flow Reversal System is a unique neuroprotection technology that reverses the flow of blood at the treatment site prior to crossing the lesion. Flow reversal is achieved by selectively occluding common carotid and external carotid artery blood flow. By establishing an arterio-venous shunt, blood from collateral vessels via the Circle of Willis is redirected to the lower pressure venous return. Macro and micro emboli are continuously directed away from the brain during flow reversal.

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Gore Receives FDA Approval for Modification to GORE TAG Thoracic Endoprosthesis

With More Than 30,000 Devices Distributed Worldwide, the Premiere Choice for the Treatment of TAA is Now Available with an Improved Catheter Delivery System

FLAGSTAFF, Ariz.--(HSMN NewsFeed)--W. L. Gore & Associates (Gore) today announced at the annual International Congress of Endovascular Interventions XXII, that it has received approval from the US Food & Drug Administration (FDA) to market a modified version of the GORE TAG Thoracic Endoprosthesis for the treatment of thoracic aortic aneurysms (TAAs). The improved delivery catheter enhances the previous version of the GORE TAG Thoracic Endoprosthesis by adding a soft flexible tip to the leading end of the delivery system. The soft tip improves flexibility at the wire / catheter interface to facilitate tracking through challenging aortic anatomy. The hub component has also been modified to improve ease of use and durability.

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Johnson Medtechs non-magnetic motors power the worlds first MRI-guided prostate cancer treatment device

2009 FEB 10 - (NewsRx.com) -- Johnson Medtech, the medical products division of Johnson Electric, one of the world's largest providers of motion actuators, announced its participation in creating the world's first MRI-compatible image-guided tumor treatment device with Profound Medical Inc.(PMI). This revolutionary tissue coagulation device is expected to treat prostate cancer in a fraction of the time and cost of existing methods, based on extensive modeling, simulation and pre-clinical trials. Critical to the success of the system, Johnson Medtech's non-magnetic "Nanomotion" actuators enable the precision of motion and accuracy of treatment necessary for safely conducting the image-guided prostate cancer therapy within the strong magnetic field of the MRI (see also Prostate Cancer).

PMI's device uses an MRI for imaging and a proprietary planar ultrasound applicator for treatment. The MRI precisely guides the probe that heats the cancerous tissue to effectively destroy the diseased area. In the past, the magnetic nature of electric motors and their metal components made it impossible for motorized medical devices to function within the MRI environment. To overcome this challenge, PMI selected Nanomotion's HR2-1-N-3 piezo ultrasonic non-magnetic motors to rotate the device's probe. When combined with the real-time non-invasive visibility into the human body provided by the MRI, the sophisticated low-speed Nanomotion actuators in PMI's device enable medical professionals to operate the probe at a microscopic scale to conduct this groundbreaking procedure.

Full text >> http://www.johnsonelectric.com/What-s-New.69+M51afedd3108.0.html

Health Discovery Corporation Licenses New Prostate Cancer Test to Abbott

SAVANNAH, Ga.--(BUSINESS WIRE)--February 5, 2009--Health Discovery Corporation (OTCBB: HDVY) today announced that it has entered into an agreement with Abbott (NYSE: ABT) to commercialize HDC’s new molecular diagnostics gene-based tests for clinically significant prostate cancer. Abbott has acquired co-exclusive clinical laboratory rights and exclusive in vitro diagnostic rights for commercialization of HDC’s tissue-based prostate cancer test as well as HDC’s urine-based prostate cancer test.

Full article >> http://www.emailwire.com/release/19479-Health-Discovery-Corporation-Licenses-New-Prostate-Cancer-Test-to-Abbott.html

FluoroPharma Obtains US Patent for Imaging Cardiovascular Plaque using FDG

2009 FEB 13 - (NewsRx.com) -- FluoroPharma Inc., a company developing breakthrough molecular imaging agents for the Positron Emission Tomography (PET) market, announced that the United States Patent and Trademark Office issued U.S. Patent No. 7,438,891, covering methods of imaging cardiovascular plaque formation using F18 labeled 2-fluorodeoxy-D-glucose (FDG). This patent, exclusively licensed from the Massachusetts General Hospital, provides FluoroPharma with additional patent claims that cover imaging of atherosclerotic plaque inflammation and rupture (see also Patents).

"The use of 18F-FDG PET for imaging atherosclerosis, for tracking inflammation within plaque and for monitoring the response to drug therapy is promising and should be part of future diagnostic armament," said Dr. David Elmaleh, FluoroPharma founder and Chief Scientific Advisor.

"Molecular imaging of the inflammatory status of vulnerable atherosclerotic lesions is of paramount importance for the identification of patients at risk for a future heart attack or stroke," said Dr. Tom Brady, Director of Nuclear Medicine and Molecular Imaging Division at the MGH, "In vivo noninvasive clinical studies to measure carotid plaque inflammation show that 18F -FDG PET imaging can identify a subset of patients with carotid atherosclerosis that may benefit from intensified medical therapy or carotid artery intervention to prevent stroke."

Full text >> http://www.pharmalive.com/News/Index.cfm?articleid=599923

Noninvasive ExAblate® Treatment for Uterine Fibroids is Cost-Effective, New Study Says

2009 FEB 12 - (NewsRx.com) -- GE Healthcare and InSightec announced that new data show that the non-invasive ExAblate® 2000 Magnetic Resonance-guided Focused Ultrasound (MRgFUS) system is more cost-effective than myomectomy or Uterine Artery Embollization (UAE). The study appears in the January 2009 issue (Vol. 25, Issue 1) of The International Journal of Technology Assessment in Health Care (see also GE Healthcare).

“This study shows that treating uterine fibroids with MRgFUS is a cost-effective option for payers” said David Lee Ph.D., Senior Director, Health Economics and Outcomes Research, GE Healthcare. “With any healthcare treatment, there is the direct cost of the procedure, but there’s also the indirect cost of lost productivity, all the more crucial in today’s economy.”
Study results show that ExAblate patients enjoy a greater number of quality-adjusted life-years (QALYs) than those who undergo a myomectomy or a hysterectomy (17.36 vs. 17.31 and 17.18, respectively). ExAblate lifetime treatment costs were less than a myomectomy or uterine artery embolization, but more than hysterectomy, the most invasive of all procedures. “Taken together, the ratio of benefits to costs for ExAblate was well within accepted standards for cost-effectiveness,” said Dr. Lee.

Full article >> http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20090128005808&newsLang=en

Alma Lasers Announces FDA Clearance of the UniForm Handpiece

2009 FEB 13 - (NewsRx.com) -- Alma Lasers Ltd. ("Alma"), a leader in laser, light and radiofrequency-based aesthetic devices, announced the FDA clearance and immediate availability of the UniForm handpiece. The UniForm is the fifth module available on the Accent(TM) XL radiofrequency device. The UniForm has received FDA clearance for "the temporary reduction in the appearance of cellulite."

The UniForm handpiece is comprised of Alma's propriety UniPolar technology for the delivery of RF therapeutic heat into the dermal and subdermal tissue, accompanied by a mechanical massager component. The mechanical component increases circulation in the subcutaneous tissues producing superior results (see also Alma Lasers Ltd.).

Press release >> http://news.prnewswire.com/DisplayReleaseContent.aspx?ACCT=ind_focus.story&STORY=/www/story/01-26-2009/0004960430&EDATE=

Immunomedics' hPAM4 Labeled With Yttrium-90 Receives Fast Track Designation From FDA for Therapy of Pancreatic Cancer

MORRIS PLAINS, N.J., Feb. 5, 2009 -- (HSMN NewsFeed) -- Immunomedics, Inc. (NasdaqGM:IMMU ), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that it has received notice from the U.S. Food and Drug Administration (FDA) granting yttrium-90-labeled hPAM4 Fast Track designation for the treatment of pancreatic cancer.

The fast track programs, under the FDA Modernization Act of 1997, are designed to facilitate drug development and to expedite the review of new drugs that are intended to treat serious or life threatening conditions. Compounds selected must demonstrate the potential to address unmet medical needs. The fast track designation allows for close and frequent interaction with the agency. A designated fast track drug may also be considered for priority review with a shortened review time, rolling submission, and accelerated approval if applicable. The designation does not, however, guarantee approval or expedited approval of any application for the product.

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Breast Cancer Clinical Results Show Test Can Differentiate Normal, Early and Later Stage Cancers

TORONTO, Feb. 5 (HSMN NewsFeed) - Predictive medicine company PreMD Inc. (TSX: PMD; PREMF.pk) today announced that its recently completed clinical trial data was presented at the 4th Annual Academic Surgical Congress in Fort Myers, FL. The peer reviewed data was presented by Dr. Anees B. Chagpar from the University of Louisville. The presentation entitled, "Quantitative Galactose Oxidase Schiff's reaction in Nipple Aspirate Fluid may distinguish women with or without Breast Cancer" concluded by stating that "GOS reactivity as measured by adjusted chroma values are significantly different between normal patients, those with Ductal Carcenoma In Situ and those with invasive cancer" and that "these results warrant further investigation".

"We are extremely pleased that the data was supportive of this novel breast cancer test and that the investigators feel that there is a need to continue to explore the potential of this test, and thus confirm that there is value to the technology. However, it is clear that funding to develop these potentially valuable tests is not readily available today and as such, work on this test will cease, at least for a while," said Dr. Brent Norton, President and CEO of PreMD Inc. "We are hopeful that one or more interested parties' steps forward to invest in or acquire this technology as it has the potential to advance the fight against this disease," he added.

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Minocycline/Rifampin-Impregnated Catheters Proven Clinically Effective in Preventing and Combating Potentially Fatal Bloodstream Infections

Antimicrobial technology unique to Cook's Spectrum(R) catheters shown to be most effective in preventing infections that kill over 91,000 Americans a year

BLOOMINGTON, Ind.--(HSMN NewsFeed)--Minocycline/rifampin-impregnated catheters are a critical component in modern health care practices designed to eliminate potentially fatal catheter-related bloodstream infections (CRBSIs) that affect 250,000 Americans a year, according to recently released clinical data from the Society of Critical Care Medicine’s 38th Critical Care Congress. The first set of data reveal that an over-the-wire exchange of an infected central venous catheter (CVC) for a CVC impregnated with minocycline and rifampin, which are two antibiotic drugs that act together to dramatically reduce the risk of infections, can more quickly help eliminate an existing infection in cancer patients than currently recommended procedures. The second, a first ever head-to-head study that lasted 46 months, revealed that minocycline/rifampin-impregnated CVCs are nearly twice as effective at preventing CRBSIs than second generation CVCs coated with a chlorhexidine/silver sulfadiazine solution.

On February 2, 2009, Issam I. Raad, M.D., professor and chairman of infectious diseases at The University of Texas M. D. Anderson Cancer Center, presented data from a study of more than 100 cancer patients that had developed CRBSIs. The results demonstrated that exchanging an infected CVC for a CVC impregnated with minocycline and rifampin was significantly more effective at resolving the potentially fatal symptoms associated with CRBSIs, including acute fever and bacteremia, within 72 hours of insertion.

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Allium introduces first-ever Bladder-Neck Stent

Removable stent provides viable solution to patients recovering from complications of bladder and prostate cancer operations

CAESAREA, Israel – February 3, 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 a CE mark for its large caliber, removable posterior urethral stent. This is a novel solution for patients who developed a stenosis at the bladder neck after radical removal of the prostate or the bladder for cancer.

“As the fourth stent to receive a CE Mark, Allium’s technology is rapidly gaining an established presence throughout Europe as more hospitals and physicians discover the significant advantages of using removable stents as an effective solution,” said Limor Domnitz Gishri, CEO of Allium Medical. “Allium is at the forefront of the expanding stent industry, developing the only next generation stents designed to fit site specific areas in the urinary and gastro-intestinal tracts. Allium’s goal is to provide the global medical market with the tools to enhance patient treatment, comfort and quality of life with a minimally invasive approach."

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Globus Medical's SIGNATURE(TM) Spacer Designed for MILDER(TM) TLIF Procedures

AUDUBON, Pa., Feb. 3 (HSMN NewsFeed) -- Globus Medical, Inc., the largest privately held spinal implant manufacturer in the world, today announced the introduction of the PATRIOT SIGNATURE(TM) TLIF Spacer system designed for TLIF procedures. The SIGNATURE(TM) TLIF Spacer is the latest addition to Globus Medical's portfolio of MILDER(TM) Spine Care products.

The SIGNATURE(TM) TLIF Spacer system includes an articulating implant that enables surgeons to utilize a single instrument--from insertion through final placement--to deliver the spacer into the biomechanically ideal position through a portal or small incision. The ease of placement allows the surgeon to restore the natural lordotic alignment of the spine while employing an MIS approach. The system is designed to permit preservation of a significant portion of the musculature that lies between the skin and the surgical site on the spine while using a portal or mini-open technique.

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Smith & Nephew Announces Agreement with the OREF Regarding Grants to Support Research and Education in Orthopaedics

MEMPHIS, Tenn., Jan. 30 /PRNewswire-FirstCall/ -- Smith & Nephew, Inc. (NYSE: SNN, LSE: SN) announced today that its Orthopaedics Reconstruction Division has entered into a grant administration agreement with the Orthopaedic Research and Education Foundation (OREF).
Under the agreement, Smith & Nephew's first with a third-party administrator of grants, OREF will assist Smith & Nephew in continuing its long-standing support of research and education in orthopaedics. The multi-year agreement is unique among the major joint replacement makers in that it covers graduate medical education, including fellowships and residency enhancement programs, as well as continuing medical education (CME) and research. This comprehensive approach gives Smith & Nephew a platform from which to support consistent education and innovation in orthopaedics.

Press release >> http://biz.yahoo.com/prnews/090130/clf064.html?.v=84

Cook Medical Launches New Interventional Radiology Business Unit to Further Advance Fundamental and Critical Field of Medical Care

New division demonstrates Cooks unwavering commitment to interventional radiologists

BLOOMINGTON, Ind.--(HSMN NewsFeed)--Committed to broadening and reinvigorating the field of interventional radiology, Cook Medical today launches its Interventional Radiology Strategic Business Unit (SBU), which will support interventional radiologists who now perform many oncology, non-vascular and venous procedures in addition to angiographic procedures. The new SBU is dedicated to advancing the field of interventional radiology through significant investments in the development of new medical devices and technologies, which will empower and enable interventional radiologists to improve patient outcomes with skills and procedures best performed in interventional radiology labs.

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MedWaves, Inc. Receives MDD CE Certification and Additional U.S. FDA 510(k) Clearance to Market Its Patented Microwave Coagulation/Ablation

SAN DIEGO, Feb. 2 (HSMN NewsFeed) -- MedWaves, Inc. announces the receipt of Medical Device Directive (MDD) CE Mark Certification. This is in addition to having already received U.S. FDA 510(k) clearance to market the Company's patented Microwave Coagulation/Ablation System for surgical applications. The system and single patient use devices enable surgeons and interventional radiologists to treat soft tissue problems, such as tumors, using microwave thermal ablation. The clearance sets the stage for rapid expansion of the Company's product portfolio and indications for use through additional U.S. FDA clearances. The Company's proprietary technology focuses on the development of minimally invasive devices in wide ranges of size, shape and flexibility intended to meet clinicians' requirements for treatment of tumors in bone, liver, lung and other locations.

MedWaves Microwave Coagulation/Ablation System overcomes limitations of existing microwave and radiofrequency (RF) thermal ablation technologies, the standard of treatment for cancerous tumor patients who are not candidates for resection surgery. For these patients, microwave ablation can be adjunctive or a replacement for the curative and/or palliative therapies of standard therapies, such as chemotherapy and/or radiation. It can be an option for patients where other thermal modalities are not possible due to tumor size, location or patient condition.

Full text >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027120

Pathway Medical Technologies Receives FDA 510(K) Clearance for Jetstream G2 System

New Technology Delivers Highly Effective, Minimally Invasive Treatment for Entire Spectrum of Peripheral Artery Disease

KIRKLAND, Wash.--(HSMN NewsFeed)--Pathway Medical Technologies, Inc., an innovator of endovascular treatments for peripheral arterial disease (PAD), today announced that the U.S. Food & Drug Administration (FDA) has granted the company 510(k) clearance to market its newest peripheral atherectomy catheter for use in the treatment of PAD in the lower limbs. Jetstream G2™ is the latest technology innovation from Pathway and is capable of treating the entire spectrum of disease found in the PAD patient, including hard and soft plaque, calcium, thrombus and fibrotic lesions, with consistent results.

“Jetstream took conventional atherectomy procedures to the next level, enabling physicians to remove all types of both hard and soft tissue plaque with a single device and greatly improving the way patients are treated for peripheral artery disease,” said Pathway Medical Technologies President and CEO Paul Buckman, “Jetstream G2 is a major milestone for the company and the industry, and we firmly believe that this enhanced technology will significantly increase the number of PAD sufferers for whom atherectomy is a viable treatment option. Today’s news further underscores and validates Pathway’s continued commitment to delivering innovative technologies for the minimally invasive treatment of a condition that affects millions of people across the U.S.”

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Azzalure Receives Approval in Europe for Treatment of Glabellar Lines

PARIS & LAUSANNE, Switzerland--(HSMN NewsFeed)--Ipsen (Paris:IPN ), an international innovation-driven specialty pharmaceutical Group, and Galderma, the leading pharmaceutical company in dermatology, today announced that Azzalure®, a muscle relaxant specifically developed for aesthetic use, has received the collective green light from 15 European countries’ Health Authorities for the granting of national marketing authorizations. The assessment was based on clinical trials involving more than 2,600 patients, which confirmed the safety and efficacy of Azzalure®.

Stéphane Thiroloix, Ipsen’s Executive Vice-President in charge of Corporate Development said: “The collective green light from Health Authorities for Azzalure® confirms the quality of our botulinum toxin, backed by solid clinical data. In addition, this decision rewards the great work accomplished by the Ipsen and Galderma teams”. Stéphane Thiroloix added: “Once the local marketing authorizations are granted, we are convinced that Galderma’s expertise and sales force, combined with a product such as Azzalure® will efficiently bring a new treatment alternative and advancement for patients and the medical community”.

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