Acorn Cardiovascular to Conduct 50-Patient Confirmatory Trial for FDA Approval of CorCap(TM) Cardiac Support Device
5/10/2007 3:09:15 PM
ST. PAUL, Minn.--(BUSINESS WIRE)--Acorn Cardiovascular announced today that the Food and Drug Administration (FDA) will consider approval of the CorCap Cardiac Support Device (CSD) based on the successful completion of a prospective confirmatory trial that addresses issues raised by the Medical Device Dispute Resolution Panel and the Circulatory System Devices Panel. The company had completed a 300-patient prospective, randomized pivotal trial and submitted data to the FDA in 2004. However, the two panels voted against approval for the CorCap CSD in December 2006 and June 2005, respectively, citing the need for additional clinical data.