FDA approves Thoratec's HeartMate II as permanent implant
This article was originally published in Clinica
Executive Summary
The US FDA has granted Thoratec's premarket approval supplement for its HeartMate II left ventricular assist system (LVAS), allowing its use as destination therapy. The device can now be used to provide long-term cardiac support for patients with advanced heart failure who are not eligible for transplantation.
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