A Medical Device Daily
The FDA will convene its Medical Device Dispute Resolution Panel (MDDRP) tomorrow in Gaithersburg, Maryland, to consider the CorCap Cardiac Support Device, made by Acorn Cardiovascular (St. Paul, Minnesota), designed to treat enlarged hearts and potentially reduce heart failure progression.
CorCap is a mesh wrap placed around the heart to provide support of the muscle and reduce ventricular enlargement. More than 465 patients have received the new treatment, according to the company.
This marks only the second time that such a panel has been convened to determine the fate of a company’s technology (Medical Device Daily, Oct. 19, 2006).
In 2005, an FDA advisory panel recommended against approval of the device (MDD June 24, 2005). The FDA subsequently determined that a small confirmatory trial would be needed for approval. Acorn’s experts disagreed with the assessment and requested a referral to the MDDRP. This panel will evaluate the data and make a recommendation to the Centers for Devices and Radiological Health (CDRH) director.
Acorn develops treatments for patients with heart failure. The CorCap Cardiac Support Device is intended to improve the heart’s structure and function, leading to potential improvements in the quality and duration of a patient’s life.