Artificial heart launch imminent
This article was originally published in The Gray Sheet
Executive Summary
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)