This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name : GORE VIABAHN™ Endoprosthesis
Applicant: W.L. Gore & Associates, Inc.
Address: 3450 West Kiltie Lane, P.O. Box 500 , Flagstaff , AZ 86002
Approval Date: June 14, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040037a.pdf
What is it? The GORE VIABAHN® Endoprosthesis is a flexible, metallic (made from Nitinol)tubular shaped device (stent) which is lined with plastic (made from expanded polytetrafluoroethylene [ePTFE]). The device is mounted on the end of a delivery catheter and held in place by a release mechanism.
How does it work?
- The delivery catheter with the mounted GORE VIABAHN® Endoprosthesis is inserted in the femoral artery through a puncture in the leg and threaded to the blocked section of the femoral artery.
- Once the device is positioned within the blocked area, it is freed from the delivery catheter by activation of the release mechanism.
- The device is expanded within the artery , opening the blocked area to improve blood flow.
- The delivery catheter is removed from the patient leaving the device within the femoropoplitealartery of the patient.
When is it used? The GORE VIABAHN® Endoprosthesis is used in patients who have a blockage within their femor al oartery, which is caused by atherosclerotic disease. This blockage can cause pain by preventing adequate blood flow from reaching the lower leg and foot. The GORE VIABAHN® Endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference vessel diameters ranging from 4.8 to 7.5 mm.
What will it accomplish? The GORE VIABAHN® Endoprosthesis helps to keep the blocked area open and allows more blood to flow to the lower leg and foot.
When should it not be used? The GORE VIABAHN® Endoprosthesis should not be used in patients who have a blockage where full expansion of a balloon dilatation catheter has not been achieved or where blockages cannot be dilated sufficiently to allow passage of the delivery system.
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p040037