A Food and Drug Administration advisory panel issued a 7-6 opinion that the benefits of the first self-contained, implantable artificial heart probably did not outweigh its risks, but stopped short of recommending that the device not be approved. Officials at Abiomed, Danvers, Mass., developer of the AbioCor artificial heart, said in a news release that the company is committed to working with the FDA to submit additional data concerning patients' anti-coagulation and quality-of-life information. The AbioCor is intended for patients who are dying from heart failure, are not transplant candidates and are not expected to live more than a month, according to the Associated Press. It has been tested in 14 patients, all of whom eventually died, the AP reported. The first AbioCor was implanted in 2001.
FDA Panel: Artificial heart's risks may outweigh benefits
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