  
Abiomed gets FDA approval to begin clinical trials of artificial heart
Last Updated: 2001-02-01 9:30:43 EST (Reuters Health)
DANVERS, Massachusetts (Reuters) - The US Food and Drug Administration has given permission to Abiomed Inc. to begin a trial of its implantable replacement heart AbioCor.
Danvers, Massachusetts-based Abiomed said the agency granted an exemption that will allow AbioCor to be implanted in the first five patients in a clinical trial.
The company explained that AbioCor is meant to help patients who are at risk of imminent death, whose hearts are not transplantable, and cannot be helped by other available therapies.
The FDA's letter authorizing the trial requires the company to respond to a number of questions within 45 days, but initiation of the trial is not contingent on those responses.
"This FDA action will further energize us as we make final preparations at Abiomed and at the collaborating centers for the initial human implants of the AbioCor," Dr. David Lederman, Abiomed's president and chief executive, said in a news release.
The company said its implantable replacement heart is in an advanced stage of development in preparation for the human trial. Abiomed currently manufactures and sells a temporary device for patients with failing but potentially recoverable hearts.
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