Gore Receives FDA Approval for Modification of GORE VIABAHN® Endoprosthesis

* Reuters is not responsible for the content in this press release.

Tue Jun 30, 2009 8:04am EDT

Manufacturing modification of the only stent-graft approved for treatment of
both iliac and superficial femoral arteries 
FLAGSTAFF, Ariz.--(Business Wire)--
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 





Schwartz Communications, Inc. for Gore
Laura Kempke and Nicki Polatin
781-684-0770
GoreMedical@schwartz-pr.com

Copyright Business Wire 2009

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.