FDA Panel to Review Abiomed Artificial Heart

Abiomed, a manufacturer of products for circulatory care and support, has announced that the FDA will convene an expert panel of cardiovascular surgeons and cardiologists to review the groundbreaking technologies and clinical trial data behind the AbioCor artificial heart -- the first completely self-contained artificial heart to come before the FDA for review.

The special expert review panel is expected to decide June 23 on the potential approval for the AbioCor artificial heart under a humanitarian device exemption (HDE). The technology behind AbioCor is the result of more than 20 years of design, research and testing conducted by Abiomed and its collaborators. AbioCor is driven by a high-precision electrohydraulic system pumping seamlessly to drive consistent and stable circulation, similar to a patient's natural heart. The device also contains a microprocessor chip and internal diagnostics that continuously monitor patient vitals.

Abiomed initially submitted 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. AbioCor is designed to sustain the body's circulatory system and to extend the lives of patients who would otherwise die of heart failure.