Healthcare Industry News:  VIABAHN Endoprosthesis 

Devices Interventional FDA

 News Release - June 30, 2009

Gore Receives FDA Approval for Modification of GORE VIABAHN® Endoprosthesis

Manufacturing modification of the only stent-graft approved for treatment of both iliac and superficial femoral arteries

FLAGSTAFF, Ariz.--(HSMN NewsFeed)--W. L. Gore & Associates (Gore) today announced that it has received approval from the US Food and Drug Administration (FDA) for a manufacturing change to the GORE VIABAHN® Endoprosthesis. The modification is a result of the precision laser trimming technology which enables the removal of excess material at the device margin, resulting in a contoured edge. The device is the only stent-graft approved by the FDA for the treatment of patients suffering from Peripheral Arterial Disease (PAD) in superficial femoral artery (SFA) lesions and iliac artery lesions. In the US alone, as many as 12 million people suffer from PAD.

“I commonly use the GORE VIABAHN Device in my practice for treatment of patients with complex SFA lesions,” said Darren B. Schneider, MD, Associate Professor of Vascular Surgery and Radiology at the University of California, San Francisco. “My hope is that the laser contoured edge at the proximal end may improve flow dynamics of blood entering the endoprosthesis.”

The GORE VIABAHN Endoprosthesis is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure. The outstanding flexibility of the GORE VIABAHN Endoprothesis enables it to traverse tortuous areas of the SFA and to conform to the complex anatomy of the artery. The device was initially approved by the FDA in 2005 for treating PAD in the SFA. Later in 2007, Gore made modifications to the device which includes reducing the profile and adding a Heparin Bioactive Surface.

“Gore’s continuing practice of improving manufacturing processes and implementation of design enhancements means that physicians can reliably treat their patients with the latest technology,” said Erin Hutchinson, Associate with the Gore Peripheral Vascular Business. “Gore is fully committed to the ongoing development of this product so that interventionalists can continue to treat their patients with the most up-to-date, innovative solution.”

GORE VIABAHN Endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference diameters ranging from 4.0 – 7.5 mm. The GORE VIABAHN Endoprosthesis is indicated for improving blood flow with symptomatic peripheral arterial disease in the iliac artery lesions with reference vessel diameters from 4.0 – 12 mm.

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 tenth best company to work for by Fortune magazine. For more information, visit http://www.goremedical.com.

Products listed may not be available in all markets. GORE, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. AN0620-EN1 JUNE 2009


Source: W. L. Gore

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