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
Friday, April 10, 2009
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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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
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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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
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
Thursday, April 9, 2009
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
"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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“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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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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Monday, April 6, 2009
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
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.
Full text >> http://dialog.newsedge.com/portal.asp?site=2006120112282907013819&portlet=ep&searchfolderid=pg2006120112305702055933&action=sitetopics&block=portaldefault&related=off&searchid=612&storyid=p4BlrLfzXToWVNtbtsbOUdGXYqTYSuSRQgxukcLEIW4bDFvAq3oiOqXbk927npE1-ls&rtcrdata=off
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.
Full text >> http://dialog.newsedge.com/portal.asp?site=2006120112282907013819&portlet=ep&searchfolderid=pg2006120112305702055933&action=sitetopics&block=portaldefault&related=off&searchid=612&storyid=p4BlrLfzXToWVNtbtsbOUdGXYqTYSuSRQgxukcLEIW4bDFvAq3oiOqXbk927npE1-ls&rtcrdata=off
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/
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
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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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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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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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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Thursday, April 2, 2009
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
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
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 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
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
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.
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.
Read More >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027718
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.
Read More >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027718
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
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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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
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
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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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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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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