FDA Approves For Permanent Treatment Of Advanced Heart Failure Assist Device Pioneered By Texas Heart Institute At St. Luke’s Episcopal Hospital. Â SeeÂ LinkÂ
Although designed as a bridge-to-transplant device, the HeartMate II has proven itself sufficiently in trials to warrant its approval as a permanent device. Â Designed by the Texas Heart Institute, the continuous flow left ventricular assist device will have a significant impact for the shortage of donor hearts.
“The approval of the pump device, the HeartMate II, follows several years of clinical trials and is seen as a major milestone for patients in the United States. In any given year there are some 250,000 people who suffer from advanced heart failure, while only about 2,000 heart transplants are performed annually in the U.S.”
This remarkable technology, unlike other technologies that might claim reduced cost, improving clinical outcomes, or both, can claim that a considerable number of lives may be saved, PLUS reducing costs and improving outcomes.