FDA Okays First Artificial Heart Implants For Seriously Ill

The FDA approved the sale of AbioCor, the first completely implanted artificial heart, under the Humanitarian Use Device (HUD) provisions of the Food, Drug and Cosmetic Act, Business First reports.
   The AbioCor replacement heart, made by Danvers, MA-based Abiomed Inc., is intended for people who are not eligible for a heart transplant and who are unlikely to live more than a month without intervention.
   Devices approved under the HUD provisions are intended to treat conditions or diseases that affect fewer than 4,000 people a year in the United States, according to the FDA. The provisions allow medical devices to be approved for market if they demonstrate safety and probable benefit.
   Jewish Hospital in Louisville, an AbioCor clinical trial site that performed the first implant of the device in 2001, will be among the first hospitals in the nation to offer patients the AbioCor.
   The hospital has implanted a total of seven AbioCor artificial hearts.
   Abiomed plans to initially make the device available at only five to 10 heart hospitals. Johns Hopkins Hospital in Baltimore, Md., and Robert Wood Johnson University Hospital in New Brunswick, N.J., also have entered into letters of intent to offer the AbioCor.