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AbioCor Artificial Heart Gets FDA Humanitarian Device Exemption

This article was originally published in The Gray Sheet

Executive Summary

The first fully implantable artificial heart, more than 25 years in the making, received approval from FDA Sept. 5 as a humanitarian-use device

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Artificial heart launch imminent

Abiomed plans to launch its AbioCor artificial heart in four to five U.S. hospitals in the next several months now that the firm has gained supplemental approval from FDA for upgrades to the humanitarian use device. The product was awarded a humanitarian device exemption in September 2006 for biventricular heart failure support in patients not eligible for a transplant (1"The Gray Sheet" Sept. 11, 2006, p. 9)

Artificial heart launch imminent

Abiomed plans to launch its AbioCor artificial heart in four to five U.S. hospitals in the next several months now that the firm has gained supplemental approval from FDA for upgrades to the humanitarian use device. The product was awarded a humanitarian device exemption in September 2006 for biventricular heart failure support in patients not eligible for a transplant (1"The Gray Sheet" Sept. 11, 2006, p. 9)

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