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: Covera™ Vascular Covered Stent
PMA Applicant: C. R. Bard, Inc.
Address: 1625 West 3rd Street, Tempe, AZ 85281
Approval Date: July 30, 2018
Approval Letter: Approval Order
What is it? The Covera Vascular Covered Stent is an expandable, flexible, metal (nitinol) tube covered with a material called expanded polytetrafluoroethylene (ePTFE). The Covera Vascular Covered Stent is pre-mounted on a delivery catheter system. The device is intended for the treatment of narrowing (stenosis) or blockage of blood flow where the vein and arteriovenous (AV) access graft connect. An AV access graft is a plastic tube, usually placed in the forearm of a patient undergoing hemodialysis.
How does it work? A balloon catheter is inserted and inflated to open the narrowed segment. Then, the delivery catheter system containing the covered stent is inserted and the covered stent is placed across the opened segment. The covered stent self-expands against the vein and AV access graft to keep the area open and allow blood flow to increase.
When is it used? The Covera Vascular Covered Stent is used to re-open narrowings at the location where the AV access graft is sutured to the vein (venous anastomosis).
What will it accomplish? The Covera Vascular Covered Stent is intended to allow patients with AV access grafts to receive hemodialysis longer when compared with treatment using a balloon catheter alone. The Covera Vascular Covered Stent may also reduce the number of additional procedures needed to keep the AV access graft functional.
When should it not be used? There are no known situations in which the device should not be used.