FDA Dispute Panel to Assess Heart “Wrap”
The FDA will convene a Medical Device Dispute Resolution Panel (MDDRP) on Dec. 15 to consider the first device to specifically treat enlarged hearts and potentially reduce heart failure progression. Acorn Cardiovascular’s CorCap cardiac support device is a mesh wrap that is placed around the heart to provide support of the muscle and reduce ventricular enlargement. More than 465 patients worldwide have received the new treatment.
In 2005, an FDA advisory panel recommended against approval of the device. The FDA subsequently determined that a small confirmatory trial would be needed for approval. Acorn’s experts disagreed with this assessment and requested a referral to the MDDRP, which will evaluate the data and make a recommendation to the director of the Centers for Devices and Radiological Health (CDRH) Director.
Friday’s meeting in Gaithersburg, MD, is only the second time that the MDDRP has been convened to adjudicate a dispute between the FDA and a sponsor.