It’s been a bad week for the medgadget industry, beginning with the Guidant defibrillator recall, and now the FDA rejection of AbioMed‘s artificial heart, the AbioCor:
During a hearing, a Food and Drug Administration panel struggled with whether to recommend the agency approve or deny the application. Abiomed wanted permission to use the device in about 4,000 patients annually. The FDA usually heeds the advice of its panels.
Before the vote, one adviser, Dr. Mitchell Krucoff, asked whether the panel should just recommend “continuing research” on the device.
Cardiologists, statisticians, and others who gathered for the hearing found AbioCor statistics sobering: At least six of the 14 patients, perhaps seven, suffered life-ending strokes. Others had strokes that resulted in irreversible neurological problems. One man was comatose for 53 days after surgery.
As we blogged in April, the AbioCor device didn’t even have to prove it was effective — just humanitarian, i.e., that the benefits to patients probably outweighed the risks. The FDA didn’t agree.
Flashback: AbioCor applies for humanitarian exemption.
More at AbioMed…