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FDA Approves Heart Failure Assist Device From Texas Heart Institute

The FDA has approved a continuous-flow heart-assist device pioneered by the Texas Heart Institute (THI) at St Luke’s Episcopal Hospital (SLEH) for use as a permanent treatment for advanced heart failure.

The approval of the pump device, the HeartMate II, follows several years of clinical trials.

The company claims that the device was previously approved as a way to ‘bridge’ patients until a donor heart could be found. Today’s approval of the device as a destination therapy means those patients awaiting transplants, or those ineligible for transplants, have a badly needed new treatment option.

As the HeartMate II is small, requires less invasive surgery, is portable and has fewer moving parts than other pumps, it is expected to significantly increase the quality of life for patients.