The FDA will convene a panel to review AbioMed’s artificial heart, the AbioCor:
The special expert review panel is expected to decide on June 23, 2005 on the potential approval for AbioCor under a Humanitarian Device Exemption (HDE). This is the first-ever completely self-contained artificial heart to come before the FDA for review.
“We believe that this panel will give us immediate exposure to the experts in heart failure, as well as the general public. Our surgeons are very passionate about this technology and look forward to having the ability to offer this solution under an HDE to their patients,” commented Michael R. Minogue, Chief Executive Officer and President.
Abiomed initially submitted the AbioCor for marketing approval under HDE to the FDA in September 2004. Approval under an HDE would make the AbioCor commercially available to treat a defined subset of not more than 4,000 irreversible end-stage heart failure patients. The AbioCor is designed to sustain the body’s circulatory system and to extend the lives of patients who would otherwise die of heart failure. Its unique design allows it to be totally implanted within the body. Unlike the artificial hearts of the past, patients are not tethered to a large, air-pumping console nor do they have wires or tubes piercing their skin. The AbioCor 2 is currently being implanted in animal studies and has the potential to last longer with a 35 percent reduction in size.
As usual, the ins and outs of FDA device regulation elude me. But according to this FDA page, the “Humanitarian Device Exemption” is limited to last-resort treatment, with a mandate for 4000 or fewer uses per year. It’s progress for artificial hearts, but AbioMed is still a long way off from relieving the donor shortage.
More at AbioMed…