FDA premarket approval of the Covera covered stent for end stage renal disease patients on haemodialysis

BD has announced that the Covera vascular covered stent has received premarket approval by the US Food and Drug Administration (FDA) for use in treatment of end stage renal disease patients on haemodialysis. The company states their device is the first and only covered stent to be approved in the US market for use in the treatment of stenoses in native (non-stented) fistulae.

In the USA, there are more than 440,000 patients with ESRD who are surviving on haemodialysis, and the company states that the Covera covered stent has been designed to address challenging lesions in the arteriovenous access circuit. The stent is available in both a flared and a straight configuration to allow for precise sizing and apposition to the vessel wall and includes an easy-to-use thumbwheel delivery system.