BioSphere Medical Reports Results Of Study Published In Journal Of Vascular And Interventional Radiology Concerning Embosphere Microspheres

(RTTNews) - BioSphere Medical Inc. on Tuesday revealed the publication of findings of a study in the January 2008 issue of the Journal of Vascular and Interventional Radiology.
The study data indicated that the Uterine Artery Embolization or UAE or UFE performed using BioSphere's Embosphere Microspheres showed significantly better results in blocking the flow of blood from arteries that feed benign uterine fibroids, compared to procedures performed using Boston Scientific's Contour SE polyvinyl alcohol embolic administered in accordance with Boston Scientific's newly refined treatment protocol.

Court Sets Hearing Date for Diomed Preliminary Injunction Against Total Vein Solutions

ANDOVER, Mass.--(HSMN NewsFeed)--Diomed Holdings, Inc. (AMEX: DIO ), a leading developer and marketer of minimally invasive medical technologies, including its patented EndoVenous Laser Treatment (EVLT(R)) for varicose veins, today announced that the court has set January 18, 2008 as the date to hear Diomed’s request for a preliminary injunction against Total Vein Solutions in its continuing efforts to enforce its U.S. Patent Number 6,398,777 covering the endovascular laser treatment of varicose veins.

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Bard Closes Transaction to Acquire LifeStent(R) from Edwards Lifesciences

MURRAY HILL, N.J.--(HSMN NewsFeed)--C. R. Bard, Inc. (NYSE: BCR ) today announced that it has closed the previously announced acquisition of the assets of the LifeStent® product family from Edwards Lifesciences Corporation, headquartered in Irvine, California. Bard will immediately commence marketing the products globally.

full article >> http://salesandmarketingnetwork.com/news_release.php?ID=2022671

Court Sets June Trial Date in Patent Litigation

ANDOVER, Mass. — Diomed Holdings, Inc. (AMEX: DIO), a leading developer and marketer of minimally invasive medical technologies, including its patented EndoVenous Laser Treatment (EVLT(R)) for varicose veins, today announced that District Judge Maxine M. Chesney of the U.S. District Court for the Northern District of California has set June 23, 2008 as the date for the commencement of trial in the ongoing patent infringement proceeding brought by VNUS Medical Technologies, Inc. against Diomed and its co-defendants, Angio-Dynamics, Inc. and Vascular Solutions, Inc. Diomed expects the trial to last up to four weeks.
"We are pleased that the court has selected a date for the trial," stated James A. Wylie, Diomed's President and Chief Executive Officer. "We are looking forward to establishing that Diomed does not infringe the VNUS patents, and that the VNUS patents are both invalid and unenforceable."

full article >> http://www.centredaily.com/business/technology/story/330974.html

Stanford researchers publish review of US medical device regulation

Report illuminates approval pathways impacting safety; innovation

WASHINGTON, D.C. – Researchers at the Stanford University Program in Biodesign have released a review of the background, mission and statutory requirements of medical device regulation in the United States. The report, published in the December 2007 issue of the Journal of Medical Devices, highlights the differences between regulations guiding medical devices versus pharmaceuticals and underscores the complexity of the approval process and post-market surveillance administered by the Food and Drug Administration (FDA).
According to the researchers, regulation plays a key role in the design, development and commercialization of new medical technologies, making a comprehensive understanding of the various regulatory requirements and their practical implementation a cornerstone of successful medical device innovation. The major barriers to moving innovative technologies from the bench to the bedside in the safest and most efficient way stem from the lack of precise scientifically based data about testing, regulatory approval and health-economic evaluation processes.
The review is part of an ongoing project at Stanford to examine how medical technology is brought to market, approved for use and subsequently enhanced over time. A key goal of the research is to build a model specific to medical technology that will be of value to current and future government initiatives aimed at enhancing the efficiency and efficacy of the regulatory process for public benefit.

full article >> http://www.eurekalert.org/pub_releases/2008-01/iti-srp011008.php

Medtronic Launches AneuRx AAAdvantage(R) Stent Graft on New Xcelerant(R) Hydro Delivery System in U.S. for Minimally Invasive Treatment of AAA

Hydrophilic Coating Designed to Aid Navigation of Device through Tight and Tortuous Arteries

MINNEAPOLIS--(HSMN NewsFeed)--Continuing its record of innovation in endovascular therapies for aortic aneurysms, Medtronic, Inc. (NYSE: MDT ), today announced the U.S. market launch of the AneuRx AAAdvantage® Stent Graft on the new Xcelerant® Hydro Delivery System, which features a hydrophilic coating designed to aid navigation of the device through tight and tortuous arteries by reducing friction with the artery wall. In addition, Medtronic has also received approval from the U.S. Food and Drug Administration to introduce its latest generation of packaging materials for the launch of this product.

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Interventional Radiology Treatment Could Decrease Hysterectomy Rate by One-Third

Fairfax, Virginia - Three-year data from the largest, multi-center, prospective voluntary registry on any procedure for benign uterine fibroids showed that 90 percent of the women participating avoided a hysterectomy and of these, 85 percent had a substantial improvement in symptoms and quality of life. The registry included three-year data on 1,278 patients from 26 sites who had this minimally invasive interventional radiology treatment for symptomatic fibroids, showing uterine fibroid embolization is a durable treatment for fibroids with sustained improvement in quality of life and symptom relief. Twenty to 40 percent of American women age 35 and older, and nearly 50 percent of pre-menopausal African American women, have uterine fibroids. Of the 600,000 hysterectomies performed annually in the United States, one-third of these are to relieve symptoms caused by fibroids. "This registry data is great news for women. With uterine fibroid embolization, we could significantly decrease the hysterectomy rate in the United States" says Scott Goodwin, MD, interventional radiologist and lead author.

read the full article >> http://www.dotmed.com/news/story/5321

BioCurex Licenses RECAF Technology to Inverness Medical Innovations

(PRIME NEWSWIRE) -- BioCurex (OTCBB:BOCX) and Inverness Medical Innovations (AMEX:IMA) have announced a licensing agreement for BioCurex's RECAF(tm) material and technology.
BioCurex is a biotechnology company with patented/proprietary technology identifying a cancer marker, RECAF. RECAF (the receptor for alpha-fetoprotein) is a wide-spectrum marker present in malignant cancer cells and absent in most normal cells, allowing it to play a major role in the development of new diagnostic tests for prostate, breast, colorectal, lung and other cancers. More than three years of testing by BioCurex has confirmed RECAF's high degree of clinical sensitivity and specificity in detecting various types of cancer, even when the disease is at its earliest stage.
Under terms of the license agreement, Inverness Medical Innovations will obtain semi-exclusive worldwide rights to commercialize products using this technology. BioCurex will be paid up-front fees, product and development milestones plus royalties on product sales.

full article >> http://www.primenewswire.com/newsroom/news.html?d=134018

Celsion Abstract Chosen for Oral Presentation in Award Session at IHPBA Congress in Mumbai, India

(BUSINESS WIRE) -- CELSION CORPORATION (AMEX: CLN: 2.83, -0.10, -3.41%) today announced that the company's ThermoDox liver cancer abstract, "Phase I Study of ThermoDox (Thermally Sensitive Liposomes Containing Doxorubicin) Given Prior to Radiofrequency Ablation for Unresectable Liver Cancers" has been selected for oral presentation in the Awards Session at the 8th Annual International Hepato-Pancreato-Bilary Association (IHPBA) Congress in Mumbai, India from February 27th to March 2nd. (http://www.ihpba2008.com/)
This Congress is hosted every two years at a different international location, with leading faculty and researchers invited from nearly 50 countries to provide global perspectives on the standard of care and latest treatment options for liver cancer. Of the over one thousand abstracts submitted to the Congress, only five percent were chosen for oral presentations in the Awards Session. The presentation will be made by Dr. Ronnie T. Poon, MD, Professor of Surgery, Faculty of Medicine at Queen Mary Hospital, University of Hong Kong.

full article >> http://www.foxbusiness.com/markets/industries/health-care/article/celsion-abstract-chosen-oral-presentation-award-session-ihpba-congress-mumbai_430519_10.html

December 2007 510(k) Approvals

Listed by date of approval:

Spectranetics: spectranetics quick-cross support2 cathe

PFM Medical: modification to: t-port hp infusion port

Cook Inc.: turbo-ject peripherally inserted central; advance 18lp pta dilatation catheter

AngioDynamics: smartport ct mp port access system and l

Smiths Medical: power port-a-cath, cath ii, and p.a.s. p

Merit Medical: merit medical systems, inc., guide wire

Bard Access: mri powerport implanted port with 9.6 fr

Vascular Solutions: pronto low profile (lp) extraction cathe

Vein RX: varicath peripheral infusion catheter

Medrad: medrad stellant ct injector system with

Medical Simulation Corporation and CardioSkills(C) Company Announce the Opening of a SimSuite(R)

DENVER, Jan. 8 /PRNewswire/ -- Medical Simulation Corporation (MSC) announces the opening of a SimSuite center in Germany. MSC has entered into an agreement with CardioSkills Company, headquartered in Frankfurt, Germany. MSCand the CardioSkills team have partnered to provide an interventional skills training experience for physicians and their staff through the use ofsimulation education. Training experiences range from basic to complex procedures.
press release >> http://www.reuters.com/article/pressRelease/idUS129622+08-Jan-2008+PRN20080108

Journal of Urology Supplement Focuses on Focal Therapy as a Prostate Cancer Treatment

IRVINE, Calif., Jan. 8 /PRNewswire-FirstCall/ -- Endocare, Inc. (Nasdaq: ENDO), an innovative medical device company focused on the development of minimally invasive technologies used by urologists and interventional radiologists for tissue and tumor ablation, announced today that a Gold Supplement to the December edition of the journal Urology is focused on a series of 12 peer-reviewed studies on the use of focal therapy in the treatment of prostate cancer. The studies were conducted by a group of leading urologists and radiologists led by David Bostwick, M.D., a pathologist specializing in urology, and Gary Onik, M.D., an interventional radiologist, both of whom served as co-editors of the supplement. This is the first published scientific compendium dedicated solely to focal prostate cancer treatment. One of the leading focal treatment methods is cryoablation, or the minimally invasive freezing of the cancerous tumors to destroy them.

read the article >> http://www.streetinsider.com/Press+Releases/Journal+of+Urology+Supplement+Focuses+on+Focal+Therapy+as+a+Prostate+Cancer+Treatment/3247719.html

BSD Medical Receives Letter from FDA on BSD-2000 Submission

SALT LAKE CITY--(HSMN NewsFeed)--BSD Medical Corporation (AMEX:BSM ) today announced that it received a letter from the Food and Drug Administration (FDA) regarding its Premarket (PMA) submission for the BSD-2000 Hyperthermia System. The letter from the FDA provides guidance as to amendments needed to make the PMA approvable. The company is currently preparing its response to the amendments proposed by the FDA.
On July 31, 2007, BSD provided detailed answers to a significant number of questions from the FDA following its initial review of the BSD-2000 PMA submission. This letter is the only response to the submission that BSD has received from the FDA since it provided answers to the FDA’s questions in July.

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read more about Hyperthermia >> http://www.heatcancer.com/

Boston Scientific Completes Sale of Cardiac Surgery and Vascular Surgery Businesses

NATICK, Mass., Jan. 7 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today announced that it has completed the sale of its Cardiac Surgery and Vascular Surgery businesses to the Getinge Group of Sweden for $750 million in cash. The sale follows the definitive agreement announced on November 5, 2007.

The Company expects to record after-tax charges of approximately $240 million in connection with the transaction. These charges will be recorded during the fourth quarter of 2007 and the first quarter of 2008."We have now sold three of our five previously identified non-strategic businesses, and we expect to close on the remaining two -- Fluid Management and Venous Access -- this quarter," said Jim Tobin, President and Chief Executive Officer of Boston Scientific.
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New dialysis provider forms, Reliant Renal Care Inc.

Reliant Renal Care, Inc. (RRC), a comprehensive outpatient dialysis provider, announces its company formation with the initial placement of $50 million in private equity for acquisitions and development.
Reliant Renal Care develops, acquires, and operates outpatient treatment centers for patients suffering from chronic kidney failure. Reliant Renal Care is a renal disease management company that affiliates with selected nephrology physician practices and hospital systems to develop health care delivery systems in markets throughout the United States.

read the full article >> http://www.nephronline.com/nephnews/index.php?option=com_content&task=view&id=1958&Itemid=131

CoolTouch Introduces CoolLipo(TM) Laser System, Recently FDA Cleared forLaser-Assisted Lipolysis

ROSEVILLE, Calif., Jan. 7 /PRNewswire/ -- CoolTouch Inc., a pioneeringmanufacturer of medical lasers, announced today that the CoolLipo(TM) 1320 nmlaser system received an additional 510(K) clearance from the U.S. Food and Drug Administration for laser lipolysis or melting fat. The CoolLipo 1320 laser is designed to ablate fat in areas such as the neck, chin and arms andimproves the outcome of conventional liposuction in larger areas such as the abdomen and thighs. In addition, the unique 1320 nm wavelength tightens theskin from the inside out by directly targeting collagen and connective tissue.The CoolLipo procedure is performed in a physician's office under local anesthesia. Patient benefits include minimal, if any bruising, and less recovery time and cost than a face or neck lift.
full article >> http://www.reuters.com/article/pressRelease/idUS68681+07-Jan-2008+PRN20080107

Cardica Receives $2 Million Payment From Cook Medical for Successful Completion of Multiple Milestones

Cardica Attains Fourth Milestone in Vascular Closure Device Collaboration Agreement and Completes Initial Development Milestone for Device to RepairHeart Defects -

REDWOOD CITY, Calif., Jan. 7 /PRNewswire-FirstCall/ -- Cardica, Inc.(Nasdaq: CRDC) today announced that it has received nearly $2 million inpayments from Cook Medical (Cook) for the achievement of significantmilestones pursuant to its development agreements with Cook. Cardica receivedthe fourth and final milestone payment of $500,000 for the delivery of theCook Vascular Closure Device (CVCD), an innovative automated system designedto close access openings in femoral arteries after interventional vascularprocedures. Cook also paid $1.3 million to Cardica for the successfulcompletion of the first phase of design and development of a specializeddevice designed to close holes in the heart known as patent foramen ovales(PFO), genetic heart defects.

press release >> http://www.reuters.com/article/pressRelease/idUS107166+07-Jan-2008+PRN20080107

Penumbra, Inc. Announces 510(k) Clearance of the Penumbra System(TM)

Device to Be Available for Immediate Commercialization; ClinicalData From 125 Patient Pivotal Trial to Be Released at the ASAInternational Stroke Conference in New Orleans on February 22, 2008

SAN LEANDRO, Calif.--(Business Wire)--Penumbra, Inc. today announced the 510(k) clearance by the US Foodand Drug Administration of the Penumbra System, which is indicated foruse in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within 8hours of symptom onset. Penumbra will commence the immediatecommercialization of the device in the United States.

full article >> http://www.reuters.com/article/pressRelease/idUS94969+07-Jan-2008+BW20080107

DaVita and Phoenix-Based Southwest Kidney Institute Form Broad Partnership

El SEGUNDO, Calif., Jan. 4 /PRNewswire-FirstCall/ -- DaVita Inc. announced today that it and Southwest Kidney Institute, PLC ('SKI') have formed a wide-ranging partnership to provide dialysis and vascular access services, as well as chronic kidney disease education and research in the greater Phoenix area. The partnership will own and operate SKI's existing dialysis centers and programs designed to provide patients with access to all available treatment modalities. SKI's nephrology practice currently consists of 29 nephrologists in seven offices throughout greater Phoenix.

read the full article >> http://money.cnn.com/news/newsfeeds/articles/prnewswire/AQF00904012008-1.htm

Lawsuit filed on patent dispute

AngioDynamics accuses laser supplier of failing to defend Queensbury firm on appeal

ALBANY -- AngioDynamics Inc. is suing the supplier of laser technology used in some of its medical instruments, saying the company failed to defend the Queensbury manufacturer against patent-infringement suits brought by competitors challenging that technology.
Biolitec Inc. supplied the biolasers and laser fibers used in some of the products AngioDynamics marketed to treat varicose veins. In its supplier agreement, Longmeadow, Mass.-based Biolitec agreed to indemnify AngioDynamics and defend it against any patent claim, according to the suit filed Wednesday in U.S. District Court in Albany.
Biolitec did defend AngioDynamics in a lawsuit brought in 2004 by Diomed Holdings Inc. of Andover, Mass., but declined to continue that defense in an appeal after a judge ruled in Diomed's favor and awarded $8.36 million in damages, according to the filings. Biolitec also said it wouldn't cover that cost.
Biolitec also declined to defend AngioDynamics in a second patent infringement suit brought in 2005 by VNUS Technologies Inc. of San Jose, Calif., that is ongoing.

full article >> http://timesunion.com/AspStories/story.asp?storyID=652337&category=BUSINESS&newsdate=1/4/2008

Arrow Medical engineers new approach to Deep Vein Thrombosis

Arrow Medical Ltd has provided product development, production engineering services, assembly and distribution support to Medical Devices Technology International (MTDI) for the new Physio-Master, a self-inflating precision foot cushion that can reduce the risks of Deep Vein Thrombosis (DVT).The Physio-Master helps patients to replicate the action of walking, to benefit blood circulation and also aids rehabilitation of lower limb circulatory problems, such as lymphoedema and swollen ankles. It can also help patients with balance problems by supporting improvements in pro-prioception, which, while assisting the elderly and other patients recovering after injury, also helps athletes improve reaction times.

press release >> http://www.sourcewire.com/releases/rel_display.php?relid=35974&hilite=

FDA Marketing Clearance for the "Vicorder" New Portable Device to Detect Peripheral Vascular Disease

Jan 2, 2008--(HSMN NewsFeed)--PHYSICIANS Resource Network, Inc today announced the FDA has granted 510(k) marketing clearance for the Vicorder manufactured by Skidmore Medical. The Vicorder is a new USB driven vascular diagnostic system which utilizes proprietary software within a Windows operating system to provide Hospitals and Vascular labs a cost-efficient method to diagnose peripheral vascular disease.

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VIBRANT Study of GORE VIABAHN Endoprosthesis Completes Enrollment

FLAGSTAFF, Ariz.--(BUSINESS WIRE)--Jan 2, 2008 - W. L. Gore & Associates (Gore) today announced that it has completed patient enrollment in the Gore VIBRANT (GORE VIABAHN Endoprosthesis veRsus bAre Nitinol stenT) Study of comparative treatments for peripheral vascular disease (PVD) of the superficial femoral artery (SFA). The Gore VIBRANT Study is a randomized, prospective, multi-center clinical trial intended to demonstrate patency superiority in the treatment of lesions eight cm or longer with the GORE VIABAHN(R) Endoprosthesis compared to bare nitinol stents. The study enrolled 150 participants at 15 study sites over the course of three years, with patency surveillance via duplex ultrasound at one-, six-, 12-, 24- and 36-month intervals.
full article >> http://www.pharmalive.com/News/index.cfm?articleid=503071&categoryid=21

BioSphere: New data shows efficacy, durability of uterine fibroid embolization

SAN FRANCISCO, Jan. 2, 2008 (Thomson Financial delivered by Newstex) -- BioSphere Medical Inc. (NASDAQ:BSMD) said Wednesday that new, three-year data demonstrated that uterine fibroid embolization produced a high level of durable long-term symptom control and resulted in a 'significant improvement' in a woman's health-related quality of life.'Three-year data from the largest, multi-center, prospective voluntary registry on any procedure for benign uterine fibroids showed that 90% of the women participating avoided a hysterectomy, and of these, 85% had a substantial improvement in symptoms and quality of life,' the Society of Interventional Radiology said in a statement.The data is from the Fibroid Registry published in the January 2008 issue of Obstetrics & Gynecology, BioSphere said.The study was funded through the Society for Interventional Radiology Foundation and, in part, from BioSphere, the company noted.

full article >> http://money.cnn.com/news/newsfeeds/articles/newstex/AFX-0013-21990628.htm

Varian Medical Systems Receives FDA 510(k) Clearance for RapidArc(TM) Radiotherapy Technology

Groundbreaking technology delivers faster, more precise cancer treatments using a unique form of volumetric arc therapy

PALO ALTO, Calif., Jan. 2 (HSMN NewsFeed) -- Varian Medical Systems (NYSE: VAR ) has received FDA 510(k) clearances for its RapidArc(TM) radiotherapy technology, a revolutionary advance that makes it possible to deliver image-guided, intensity-modulated radiation therapy (IMRT) two to eight times faster and more precisely than is possible with conventional IMRT or helical tomotherapy.
"RapidArc represents a major medical advance that will change the way radiation therapy is planned and delivered," says Dow Wilson, president of Varian's Oncology Systems business. "Our primary goal with this product is to improve clinical outcomes. In addition, we discovered that we could simultaneously improve treatment efficiency significantly. RapidArc should make better-quality radiotherapy a more affordable, more accessible treatment option, and enable more cancer patients to receive a higher standard of care."

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