Based on registry data, FDA revises Sapien label

The FDA broadened the pool of patients with inoperable aortic valve stenosis by approving revised labeling for the Sapien Transcatheter Heart Valve. The agency based its decision in part on data from the Transcatheter Valve Therapy Registry (TVTR).

The Sapien (Edwards Lifesciences) valve was approved by the FDA in November 2011 for inoperable patients with severe aortic valve stenosis using a transfemoral approach. In October 2012 it also won the FDA’s blessing for high-risk patients as well with delivery approved both transfemorally and transapically. At the time, Irving, Calif.-based Edwards Lifesciences reported that it would continue to evaluate the device with registry data.

The revised labeling opens the door for procedures using either access point in inoperable patients.

According to the FDA, Edwards Lifesciences provided data from the TVTR and device registries in Europe in addition to results from clinical trials and published studies. Data from thousands of procedures indicated that use of an alternative access point made no difference in device performance or its benefit-risk profile.

The TVTR is jointly administered by the American College of Cardiology (ACC) and Society for Thoracic Surgeons. In statements, the FDA and the ACC pointed to the role that registries can play in monitoring patients and evaluating outcomes after a device is approved.

“The FDA’s decision is a true testament to the efficiency of rigorous clinical registries, which allowed FDA to make a prompt decision that will impact thousands of patients who previously would have not had access to this procedure,” said ACC President John G. Harold, MD.

Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, called the use of device registries “a new paradigm for the FDA, researchers, registry sponsors and the medical device industry.”