FIRM TAKES PREMARKET APPROVAL DISPUTE OVER HEART FAILURE DEVICE TO FDA PANEL

The FDA's Medical Devices Dispute Resolution Panel meets today to resolve issues related to the premarket approval (PMA) application for the CorCap CSD, a device to treat congestive heart failure manufactured by Acorn Cardiovascular.

The device is a polyester mesh wrap placed around the heart to support the organ's structure and function. The wrap is designed to halt or reverse the progression of congestive heart failure, and comes in six sizes.

The Circulatory System Devices Panel in June 2005 recommended 9-4 against approval of Acorn's PMA application for the device. The panel members voting against approval cited:

A lack of clinical outcome data;

The number of patients with missing data; and

Safety concerns regarding potential long-term complications from device placement.

The dispute resolution panel meeting was convened based on the rationale that the circulatory devices panel deliberations were not fully informed, and that the June 2005 panel meeting was held prior to Acorn's submission of an amended PMA application.

For more information on the panel meeting, go to www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4269b1-index.htm (http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4269b1-index.htm).