IDE Study

Announcement: FDA Expands Indication for Transcatheter Heart Valve

The U.S. Food and Drug Administration (FDA) has approved revised labeling for the Sapien Transcatheter Heart Valve (THV), making the device available to an expanded group of patients who have inoperable aortic valve stenosis.

Data from the STS/ACC TVT Registry™, created by ACC and the Society of Thoracic Surgeons (STS) to monitor the safety and efficacy of transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis, played a key role in the decision to expand the indication. Data from Europe’s transcatheter heart valve registries, clinical studies and medical journals were also used to support the update.

“The TVTR data came from several thousand procedures performed on patients using an alternative access point and showed no evidence that the device performs differently or has a different benefit-risk profile based on the access point,” noted the FDA. “The manufacturer will continue to use data from the TVTR to study short- and long-term patient outcomes of THV procedures using alternative access sites.”

In 2012, the Centers for Medicare and Medicaid Services announced approval of a National Coverage Determination (NCD) of TAVR. The NCD covers TAVR when performed with a FDA-approved device consistent with labeled indications and any other FDA requirements. In addition, it permits Medicare coverage only in facilities meeting certain requirements. The NCD also requires all patients to be included in a national TAVR registry, such as the STS/ACC TVT Registry.

STS/ACC TVT Registry participants who enrolled patients while the Alternative Access for Inoperable Patients Investigational Device Exemption (IDE) Study was active we will be contacted with further details as soon as they are available.