FDA Approves Thoratec's Heartmate II LVAD for Destination Therapy

Reed Miller

January 21, 2010

January 21, 2010 (Silver Spring, Maryland) — Thoratec's HeartMate II is the first continuous-flow left-ventricular assist device (LVAD) approved by the FDA for transplant-ineligible heart-failure patients [1].

The FDA announced January 20 that it has approved HeartMate II as a destination therapy for patients with end-stage (NYHA class 3b or 4) heart failure who are not suitable for cardiac transplant. The FDA originally approved HeartMate II as a "bridge to transplant" in 2008, and the device has been available in Europe for both indications since November 2005.

As reported by heartwire , Thoratec's application for the destination-therapy indication was based on a 200-patient trial that randomized patients to receive either a HeartMate II or the first-generation HeartMate XVE pulsatile pump. The patients in the study had NYHA class 3b or 4 heart failure with a mean left-ventricular ejection fraction of 17%, and 80% were on intravenous inotropes. Of the 134 patients randomized to HeartMate II, 62 survived at least two years on the device stroke-free. Only seven of the 66 patients randomized to the HeartMate XVE survived two years without a stroke or surgery to repair or replace their device.

As a condition of approval, Thoratec will continue to collect data on the performance of the HeartMate II to be submitted to the Interagency Registry of Mechanical Assisted Circulatory Support (INTERMACS), a registry run by FDA, the National Heart, Lung and Blood Institute at the National Institutes of Health, the Centers for Medicare & Medicaid Services (CMS), LVAD manufacturers, and the implanting hospitals.