Abiomed Says FDA OKs AbioCor Heart Patient Group
CHICAGO (Reuters) – Medical device maker Abiomed Inc. said on Monday that U.S. regulators have taken preliminary steps toward approval of its implantable artificial heart as a last-resort treatment for patients with end-stage heart failure.
Abiomed said the U.S. Food and Drug Administration has agreed upon a population of end-stage heart failure patients who might benefit from the AbioCor device. The AbioCor heart is a grapefruit-sized titanium and plastic device that is completely implanted in a patient’s body.
The company said it will now seek approval to sell the product under a humanitarian device exemption. The designation is for products aimed at a defined group of patients who have no clinical alternative available and for whom the potential benefits outweigh the risks.
Abiomed spokesman Edward Berger said the company must now demonstrate the product’s functional benefits based on results from its clinical trial.
That trial resumed in January after a nine-month hiatus during which Abiomed modified the device to make it less prone to forming blood clots and causing strokes.
To qualify for the AbioCor trial, patients had to be gravely ill with less than 30 days to live and could not be candidates for a human heart transplant.
Berger said the company hopes to receive marketing approval by the second half of 2004.
