Abiomed AbioCor
This article was originally published in The Gray Sheet
Executive Summary
A humanitarian device exemption will be submitted to FDA by the end of 2003, contingent on patient experiences in the ongoing clinical trial and on FDA approval of a qualifying population, Danvers, Mass.-based firm tells Banc of America Securities conference attendees in Las Vegas March 25. The firm expects to implant eight more AbioCor hearts in the U.S. and Europe this year for a total of 15 (1"The Gray Sheet" March 17, 2003, p. 17)...