A Medical Device Daily

Abiomed (Danvers, Massachusetts) said that surgeons implanted its AbioCor artificial heart in a patient for the first time outside of a clinical trial.

Mark Anderson, MD, of the Robert Wood Johnson University Hospital in New Jersey, implanted the self-contained device in a 76-year-old man with congestive, end-stage heart failure. The AbioCor Total Replacement Heart is mostly made of titanium and plastic, and is designed to be fully implantable.

The hospital said the device has an internal motor that simulates a heartbeat, along with a rechargeable battery. Older artificial hearts have external power devices that patients must keep with them at all times.

This is the first AbioCor implant since the completion of clinical trials and Humanitarian Device Exemption approval from FDA in 2006 (Medical Device Daily, Sept. 7, 2006).

"The AbioCor is designed to give end-stage heart failure patients another treatment option to extend their quality of life when they are ineligible for all other medical therapies," said Michael Minogue, chairman/president/CEO of Abiomed.