FDA Panel Rejects First Artificial Heart

Bram Zuckerman, the FDA’s division director of cardiovascular devices, said the agency and Abiomed would carefully go through the meeting’s transcript and “develop a plan to move forward,” according to the Wall Street Journal.

Panel members were concerned that most of the 14 patients who received the device suffered from bleeding complications, and that half the patients died of a stroke. They were put on blood-thinning medication, but regulating the medication became difficult.

“I think the bleeding and the strokes are a deal-breaker for me,” said Christopher J. White, a panel member and cardiologist at the Ochsner Clinic in New Orleans.

The device was implanted in 14 men with severe heart failure who had less than 30 days to live. All have since died after living for an average of 5.2 months following implant.