Abiomed receives FDA approval for AbioCor artificial heart

New York, Sept. 5 - Abiomed, Inc. said it received Humanitarian Device Exemption approval from the Food and Drug Administration for its AbioCor implantable replacement heart, a device the company says is the first self-contained implantable artificial heart.

The Danvers, Mass., maker of heart devices said the approval will provide patients suffering from heart failure on both sides of their heart and who have no other alternative a viable option for extending the quality of their life.

With AbioCor, patients do not have wires or tubes piercing their skin.

Abiomed noted American Heart Association statistics for 2006 Statistics showing that 57,000 patients a year in the United States die from chronic heart failure. While roughly 2,200 donor hearts are transplanted into patients suffering from heart failure, there are many more patients for whom a heart transplant is not an option because of advanced age, organ failure or cancer.

The Humanitarian Device Exemption approval signifies that no comparable alternative therapy exists for patients facing imminent death without the technology, and that it has proven to be safe and have probable benefit for patients.

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