New Indication Added for Covered Stent to Treat Hemodialysis AV Fistula

April 3, 2019 — The U.S. Food and Drug Administration (FDA) recently granted an additional indication to Bard Peripheral Vascular's Covera Vascular Covered Stent for the treatment of a stenosis or blockage which has developed anywhere in the access circuit of patients on hemodialysis using an arteriovenous (AV) fistula.

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. 

It 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 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. The tent is placed using a balloon catheter

The FDA said the Covera 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, the FDA said.

For more information: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm634191.htm?utm_campaign=2019-03-25%20Recently%20Approved%20Devices&utm_medium=email&utm_source=Eloqua