W. L. Gore & Associates has received approval for a manufacturing change to the GORE VIABAHN Endoprosthesis from the US FDA. The manufacturing change 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 GORE VIABAHN Endoprosthesis is used in treatment of patients suffering from Peripheral Arterial Disease (PAD) in superficial femoral artery (SFA) lesions and iliac artery lesions.
“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 was initially approved by the FDA in 2005 for treating PAD in the SFA. Gore reduced the profile and added Heparin Bioactive Surface to its GORE VIABAHN Endoprosthesis in 2007 modifications. The device is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure. The 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.
“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 designed for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions and superficial femoral artery lesions with reference vessel diameters from 4.0 – 12 mm (Iliac artery lesions) and in 4.0 – 7.5 mm(Superficial femoral artery lesions).