Reuters
A heart pump that has been implanted in 66,000 American patients has been tied to 49 deaths, and the manufacturer did not immediately notify federal regulators of a serious risk, officials said on Friday. But despite the concerns, the Food and Drug Administration has decided to let doctors keep using the Impella device and issued an alert about its potential to puncture the wall of the heart. Some cardiologists were disheartened the FDA did not take stronger action against the heavily promoted pumps. “To say that you’re addressing 49 deaths by saying ‘be careful’ is not addressing the problem at all.” Dr. Rita F. Redberg of the University of California-San Francisco told The New York Times. Dr. Nihar Desai of the Yale School of Medicine told the Times that there is little evidence from research to support use of the Impella over other devices, given the risks. The maker, Abiomed, said the perforations were not linked to product design and the company is enhancing physician training.