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.

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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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