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FDA approved HeartMate II for destination therapy in patients with advanced-stage HF

The device was associated with significant increases in two-year survival and quality of life improvement

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The FDA has granted approval of Thoratec’s HeartMate II left ventricular assist device, allowing the use of the device for destination therapy.

The approval allows the HeartMate II to be used in patients with NYHA Class IIIb or IV end-stage LV failure who have received optimal medical therapy for at least 45 of the last 60 days and who were not candidates for cardiac transplantation. The premarket approval supplement was submitted in April of 2009 and included two-year data from a study cohort of 200 patients randomly assigned 2:1 to either a HeartMate XVE or a HeartMate II. The HeartMate XVE is the only other FDA-approved device for use as both bridge-to-transplant and as destination therapy. According to a press release, patients implanted with the HeartMate II device had statistically significant improved two-year survival vs. those implanted with the HeartMate XVE, in addition to improved quality of life. Forty-six percent of the 134 patients implanted with the HeartMate II were still living after two years with no disabling stroke or need for reoperation, device replacement or repair, compared with 11% in the 66 patient control group.

The smaller HeartMate II device is also able to be implanted in women with greater ease than the HeartMate XVE.

Approval came with the condition that Thoratec conduct a post-approval follow-up study involving 247 patients for either two-years or until outcome. Data from the study will be recorded in the Interagency Registry of Mechanical Assisted Circulatory Support (INTERMACS). Thoratec has announced that it will begin rolling out the devices for destination therapy immediately and that they have sufficient inventory to address the expected increase in demand for the HeartMate II.

“The approval of HeartMate II provides an option for HF patients who cannot receive a transplant,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “Its smaller size and mobility should allow more patients, including women and men of smaller stature, access to treatment.”