May 15, 2007 — Acorn Cardiovascular has announced that the 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.
Since the MDDRP decision last year, Acorn Cardiovascular has worked closely with Dan Schultz, M.D., director of the Center for Devices and Radiological Health (CDRH), and Bram Zuckerman, M.D., director of the Division of Cardiovascular Devices, to design a confirmatory trial that would alleviate the concerns of the panels. Dr. Schultz is the highest-ranking official at FDA with responsibility for the assessment of medical devices.
The confirmatory trial will assess a patient population that demonstrated the greatest clinical benefit in the pivotal trial. If Acorn meets the success criteria for the confirmatory trial, it is expected that FDA may be able to approve the device without engaging a third advisory panel. It will involve 50 patients in key investigational sites selected from the original 29 pivotal trial site locations.
Dr. Michael A. Acker, chief of the Division of Cardiac Surgery at the University of Pennsylvania, will serve as principal investigator (PI) of the confirmatory trial. Sites should start enrolling patients in summer 2007, with the aim of completing enrollment in early 2008. Following a six-month follow-up period and pending positive results, the company anticipates approval to occur by the end of 2008 or the beginning of 2009.
For more information visit www.acorncv.com.