A US-based advisory panel has recommended the approval of a new implantable heart pump device that can help patients with severe heart failure.
The Food and Drug Administration (FDA) advisory panel voted 9-2 that the benefits of the machine called the HeartWare ventricular assist device (HVAD) outweigh its risks, Iranian Press TV reported.
The experts suggest that the device can effectively save the lives of many of those with end-stage heart failure that are waiting in the heart transplantation raw. “Overall, this is a novel device for a desperate population, and I hope it will be available soon,” said Dr. David Slotwiner, a member of the FDA’s Circulatory System Devices panel. According to estimates, nearly 50,000 patients worldwide are candidates for heart transplants while only 5,000 of them would reach a new heart each year.
A few days ago, however, the FDA expressed concerns about the device-related clotting rates and stroke. The FDA experts and the advisory panel both said clinical trial results may have missing data, meaning that they could have over-estimated how well the device works.
Although the influential panel has recommended HVAD’s approval, it also called for HeartWare International Inc. to conduct further safety trials in the event the FDA does endorse the device.
