Thoratec has received FDA approval of its premarket approval application, allowing the use of its HeartMate II left ventricular assist system (LVAS) as a bridge-to-transplantation (BTT) in patients suffering from advanced-stage heart failure.
“The HeartMate II is an important advance in mechanical heart technology,” said Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health. "Until now, some heart transplant candidates have been underserved due to the large size of previously approved heart assist devices.”
The agency noted that previously heart pump models were too large to be placed in the upper abdomen of some women and smaller men.
The approval follows a successful clinical trial involving more than 450 BTT patients, which resulted in a unanimous recommendation for approval from the FDA Circulatory System Devices Advisory Panel in November 2007, according to the Pleasanton, Calif.-based Thoratec.