Reuters: Regulatory News: UPDATE 1-US FDA advisers back HeartWare blood pump device

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UPDATE 1-US FDA advisers back HeartWare blood pump device Apr 25th 2012, 22:38 Wed Apr 25, 2012 6:38pm EDT WASHINGTON, April 25 (Reuters) - HeartWare International Inc won a U.S. advisory panel's support on Wednesday for its most important product: a blood pump that helps people with severe heart failure. A panel of outside experts to the Food and Drug Administration voted 9-2 to recommend approval of the mechanical heart-assist device, called the HeartWare ventricular assist device (HVAD). HeartWare shares were halted pending the panel outcome. The FDA usually follows panel recommendations, although it is not required to, and a final decision is expected later. Panelists said the device helped save lives, though they expressed doubts about the company's conduct of clinical trials and about missing safety data. "Overall, this is a novel device for a desperate population, and I hope it will be available soon," said Dr. David Slotwiner, of the Long Island Jewish Medical Center. Heart failure is a chronic condition with no cure, in which the heart is too weak to pump enough blood to meet the body's needs. In the most severe cases, people may need a heart transplant. HeartWare's device helps people with failing hearts pump blood while awaiting a transplant. The device is already approved in Europe. It is estimated that some 50,000 people around the world are candidates for heart transplant, but only some 5,000 patients per year get them. If approved, the device will compete with Thoratec Corp's HeartMate II, which has been sold in the United States since 2008. It is currently the only blood pump available to people with heart failure awaiting a transplant. Shares of Thoratec fell 1.5 percent in after-market trading. Link this Share this Digg this Email Reprints

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