Abiomed seeks US approval for artificial heart:
This article was originally published in Clinica
Executive Summary
Abiomed has submitted to the US FDA an application to market its a fully implantable heart replacement, AbioCor. The Danvers, Massachusetts firm is seeking approval under humanitarian device exemption (HDE) regulations, which allow for the product to be made commercially available as a treatment for a defined subset of not more than 4,000 irreversible end-stage heart failure patients. The AbioCor system is currently the subject of an initial clinical trial that has been approved by FDA. 14 of the initial 15 patients have been enrolled in the trial thus far. However, Abiomed notes that it is not required to enrol a 15th patient before submitting for approval under the HDE.