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FDA Approves Left Ventricular Assist System for Severe Heart Failure Patients ROCKVILLE, Md -- January 21, 2010 -- The US Food and Drug Administration (FDA) has approved the a continuous-flow, left ventricular assist system (HeartMate II) as a support for patients with severe heart failure who are not acceptable candidates for heart transplantation. “The approval provides an option for heart failure patients who cannot receive a transplant,” said Jeffrey Shuren, MD, FDA’s Center for Devices and Radiological Health, Rockville, Maryland. “Its smaller size and mobility should allow more patients, including women and men of smaller stature, access to treatment.” In a randomised study of 200 participants at 38 centres, 46% of 134 participants with the HeartMate II were still living after 2 years with no disabling stroke or need for a reoperation for device replacement or repair compared with 11% of 66 participants in the control group. In addition, data collected in a separate registry of smaller stature women and men indicated that the device worked well in this specific population. As a condition of the FDA’s approval, the company will conduct a post-approval study to further evaluate the device’s performance. The data will be recorded in the Interagency Registry of Mechanical Assisted Circulatory Support (INTERMACS) and made available when the post-approval study is concluded. SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version