Mechanical Heart Approved for Strictly Limited Use

AbioCor, a fully implantable mechanical heart manufactured by Abiomed, Inc., gained FDA approval for very limited use. “Only patients who have advanced heart failure that has affected the left and right ventricles and who are not candidates for a heart transplant will be eligible to receive the device under the agency’s Humanitarian Use Device provisions.” The mechanical heart is powered by a transfer coil placed on the skin, and can be powered at night by plugging into an electrical outlet. Last year, an FDA advisory panel voted against AbioCor approval, after evaluating data including a 14 patient clinical trial, in which all 14 of the trial participants died. The Humanitarian Use Device provisions are meant to encourage innovative medical devices to treat rare medical conditions. Only surgeons in three hospitals will be allowed to implant the device, according to Abiomed.