FDA Approves HeartMate II for Bridge-To-Transplantation
Thoratec Corp. received FDA approval of its PMA (premarket approval) application, allowing the use of its HeartMate II LVAS (left ventricular assist system) as a bridge-to-transplantation (BTT) in patients suffering from advanced-stage heart failure.
The HeartMate II is a mechanical circulatory support device intended for a broad range of advanced-stage heart failure patients. An axial flow device, the HeartMate II can pump up to 10 liters of blood per minute, the full output of a healthy heart, and is designed to provide long-term cardiac support. The device is implanted alongside a patient’s native heart and takes over the pumping ability of the weakened heart’s left ventricle.
It is easier to implant than prior devices, and with only one moving part, the HeartMate II is designed to provide exceptional reliability and improved patient quality of life. The device is designed to have a much longer functional life than the previous generation of devices and to operate more simply and quietly.