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: March 1, 2019
Approval Letter: Approval Order

What is it? The Covera™ Vascular Covered Stent is an expandable, flexible, metal (nitinol) tube-shaped device (stent) that is covered with a material called expanded polytetrafluoroethylene (ePTFE). Each covered stent is mounted on the end of a delivery catheter system.

The device was previously approved for use in the treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arterio-venous (AV) access grafts only. In this PMA supplement, FDA approved this device for the treatment of a narrowing (stenosis) or blockage which has developed anywhere in the access circuit of patients on hemodialysis using an Arteriovenous (AV) Fistula.

The access circuit begins at the point of surgical connection between an artery and a vein (AV fistula) and ends where the venous drainage of the upper arm enters the chest (i.e., the subclavian vein). The access circuit must remain open to permit hemodialysis treatments.

How does it work? A balloon catheter is inserted and inflated to open the narrowed segment at the vein. Then, the delivery catheter system containing the COVERA™ Vascular Covered Stent is positioned across the narrowed segment that has just been opened with the balloon. The covered stent is then released from the delivery catheter and self-expands so that it holds the vein open where it was previously narrowed and allows blood flow to continue.

When is it used? The Covera™ Vascular Covered Stent is used to re-open narrowings in the access circuit of an AV fistula.

What will it accomplish? The Covera™ Vascular Covered Stent should benefit patients by keeping the treated area open for a longer time compared to use of balloon angioplasty alone. The covered stent may also reduce the number of procedures needed to keep the same narrowing open, however, additional procedures may be needed for treatment of other narrowings that develop subsequent to the use of this device. The use of the Covera™ Vascular Covered Stent is associated with little added risk compared with treatment using a balloon angioplasty alone.

When should it not be used? There are no known situations in which the device should not be used.

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness Data (SSED)
• Patient Labeling: Patient Information Guide
• Physician Labeling: Instructions for Use
• PMA Database Entry