Healthcare Industry News:  VIABAHN Endoprosthesis 

Devices Interventional

 News Release - January 2, 2008

VIBRANT Study of GORE VIABAHN(R) Endoprosthesis Completes Enrollment

Randomized Trial to Assess Patency of Covered Stents v. Nitinol Stents for the Treatment of Vascular Disease

FLAGSTAFF, Ariz.--(HSMN NewsFeed)--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® 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.

The final two patients enrolled in the study were treated by Richard Begg, MD, an interventional cardiologist at Heritage Hospital, Beaverton, PA, and Arun Chervu, MD, of Vascular Surgical Associates of Austell, GA. The procedures were completed successfully on December 6, 2007.

“We are very excited about the completion of enrollment in the Gore VIBRANT Study,” said Gary Ansel, MD, co-principal investigator for the Gore VIBRANT study and an interventional cardiologist at Riverside Methodist Hospital, Columbus, OH. “We look forward to the long-term follow-up data of patients and what it could reveal about the impact that adding a bypass-like covering to a stent can have on the results of bare metal stents.”

Gore VIBRANT Study investigators include vascular surgeons, interventional radiologists and interventional cardiologists. In addition to Dr. Ansel, other co-principal investigators include Patrick Geraghty, MD, vascular surgeon, Washington University, St. Louis, MO, and Mark Mewissen, MD, interventional radiologist, St. Luke’s Medical Center, Milwaukee, WI. Dr. Mewissen enrolled 26 patients. An independent core laboratory will interpret results of the follow-up ultrasound imaging studies. Study endpoints focus on primary and secondary patency – the state of vessel blood flow – of the treated artery.

The GORE VIABAHN® Endoprosthesis is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure. The excellent flexibility of the GORE VIABAHN® Endoprosthesis enables it to traverse tortuous areas of the SFA and conform closely to the complex anatomy of the artery. Recently introduced device modifications for the GORE VIABAHN® Endoprosthesis include a lower delivery profile and a bioactive heparin-bonded surface.

ABOUT W. L. GORE & ASSOCIATES

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 25 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair and sutures for use in vascular, cardiac and general surgery. Gore was recently named the 10th best company to work for in America by Fortune.

Products listed may not be available in all markets pending regulatory clearance. GORE and VIABAHN® are trademarks of W. L. Gore & Associates. AL0788-EN1 DECEMBER 2007


Source: W. L. Gore

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