Broadened FDA Indication For GORE VIABAHN(R) Endoprosthesis For Iliac Occlusive Disease

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 21 Sep 2008 - 0:00 PDT

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W. L. Gore & Associates (Gore) announced it has received approval from the US Food and Drug Administration (FDA) to market the GORE VIABAHN Endoprosthesis for use in patients with symptomatic peripheral arterial disease in iliac artery lesions with reference vessel diameters ranging from 4.0 - 12.0 mm. The GORE VIABAHN Endoprosthesis was previously approved for use in patients with symptomatic PAD in superficial femoral artery (SFA) lesions with reference vessel diameters ranging from 4.0 - 7.5 mm.

"It is exciting that Gore was able to expand its indication for the GORE VIABAHN Endoprosthesis to the iliac arteries," said Michael D. Dake, MD, Professor of Radiology, Internal Medicine, Surgery, Chairman of the University of Virginia Department of Radiology and an investigator on the study used to obtain the iliac indication. "Gore is uniquely positioned now as the only company with a stent-graft approved for both the SFA and iliac arteries. This is an important advancement in treating patients with PAD in the iliac artery."

The iliac indication was obtained using data collected as part of the GORE VIABAHN Endoprosthesis Feasibility Study that was conducted in the US and Europe from 1996 to 1999. Data collected from this study was used to establish the GORE VIABAHN Endoprosthesis as safe and effective for treatment of iliac arterial occlusive disease when used in accordance with its labeling.

The GORE VIABAHN Endoprosthesis is a stent-graft and the only device of its kind on the market and approved for treating PVD in the SFA. The device was initially approved by the FDA in 2005 for treating SFA disease and, in 2007, two modifications to the device, a lower profile and a Heparin Bioactive Surface, were subsequently approved. The excellent flexibility of the GORE VIABAHN Endoprothesis enables it to traverse tortuous areas of the SFA and conform to the complex anatomy of the artery.

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 materials for hernia repair, soft tissue reconstruction, staple line reinforcement, and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best companies to work for by Fortune magazine for the 11th consecutive year. For more information, visit http://www.goremedical.com

Products listed may not be available in all markets pending regulatory clearance. GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates.

W. L. Gore & Associates