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 Data (SSED) 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
GORE® VIABAHN® Endoprosthesis with Heparin BioActive Surface PMA Applicant: W.L. Gore & Associates, Inc.
Address: 3250 West Kiltie Lane Flagstaff, AZ 86001
Approval Date: December 5, 2013
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130006a.pdf
What is it? The GORE® VIABAHN® Endoprosthesis is a small, expandable, flexible, metal (Nitinol) tube shaped device (stent) that is lined with plastic (made from expanded polytetrafluoroethylene [ePTFE]).
The GORE® VIABAHN® Endoprosthesis with Heparin BioActive Surface is the same as the GORE® VIABAHN® Endoprosthesis, but it is coated with bioactive heparin, a chemical intended to reduce blood clots from forming.
Each stent is mounted on the end of a delivery catheter; a long, thin, tube-like device, and held in place by a release mechanism.
How does it work?
- A catheter with a deflated balloon at its tip is inserted into a blood vessel in the groin and advanced within the vessel to an A-V access graft.
- The balloon is inflated within the narrowed vein to open it (balloon angioplasty).
- The balloon and its catheter are removed; then the stent and delivery system are advanced through the same vessel and positioned within the expanded vein.
- The stent is then released (deployed) by retracting the outer tube (sheath) after it is positioned in the vein and opens automatically so that it is pressing against the A-V access graft and blood vessel.
- The stent placement increases blood flow by holding the vein wall open.
- Once the stent is deployed, the stent delivery catheter is removed.
- The stent remains permanently implanted in the vein and acts as a support for the newly opened section of the vessel.
When is it used? The devices are used to treat narrowing or blockage in a blood vessel (stenosis) or a blood clot (thrombotic occlusion) that has developed where a vein and an arteriovenous (A-V) access graft connect, known as the venous anastomosis. An A-V access graft acts as an artificial blood vessel that goes between an artery and a vein and can be used repeatedly to draw blood with a needle during hemodialysis.
These devices are used instead of three other treatment options:
- balloon angioplasty alone;
- implanting other stent-grafts; or
- surgery to remove the blockage.
What will it accomplish? Once in place, the stent acts as a scaffold to hold the vein open and restores blood flow at the venous anastomosis of an A-V access graft.
When should it not be used? Generally, patients who are not suitable candidates for balloon angioplasty are also not suitable candidates for stent placement.
The GORE® VIABAHN® Endoprosthesis with Heparin BioActive Surface should not be used in patients with known hypersensitivity (allergic reactions) to heparin, including those patients who have had a previous incidence of Heparin-Induced Thrombocytopenia (HIT) type II.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available.