The HeartMate II Destination Therapy trial involved 200 patients enrolled at 38 centres who were randomized to the HeartMate XVE on a 2-1 basis, respectively. Patients enrolled in the HeartMate II trial ranged in age from 26-81 years old, with a median age of 64 years.
Gary F Burbach, president and chief executive officer of Thoratec said: “We find the two-year survival data, as well as that related to pump performance, adverse events, quality of life and functional status, to be highly positive. Treating patients with the HeartMate II leads to dramatically improved survival, functional capacity and quality of life beyond any other therapy for advanced-stage heart failure patients. We believe the trial outcomes will drive market adoption of the device once it receives DT approval from the FDA, given the poor outcomes with other treatment options available for these patients.”
The HeartMate II was approved for Bridge-to-Transplantation (BTT) in the US in April 2008, and the HeartMate XVE is the only device approved by the FDA for both DT and BTT. A continuous flow device, the HeartMate II is an implantable LVAS powered by a rotary pumping mechanism and is designed to have a much longer functional life than pulsatile devices and to operate more simply and quietly. The device provides blood flow through the circulatory system on a continuous basis with only one moving part. It is also smaller and easier to implant than a pulsatile device.
