A new clinical trial of Acorn Cardiovascular’s CorCap cardiac device, previously rejected by FDA advisory panels, is unlikely to yield convincing data, according to a letter sent to the director of the agency’s Center for Devices and Radiological Health by Public Citizen, a consumer group.
Acorn’s CorCap is a mesh support sock sewn around the heart during open-heart surgery for dilated cardiomyopathy, seeking to limit further enlargement of the heart. Following the only clinical trial done on the device, two FDA advisory panels recommended against the device’s approval, as did the agency itself on three occasions.
Despite the rejections, Public Citizen said that the FDA has counseled Acorn how to conduct a new study and to submit another pre-market application for CorCap, potentially leading to approval without further advisory committee review.
“In the only significant study of CorCap done to date, the device failed to help patients with enlarged hearts and put them at risk for surgical scarring and heart constriction,” said Peter Lurie, MD, deputy director of Public Citizen’s health research group.
If the FDA approves the device without further advisory committee scrutiny, the move would be a clear abdication of the FDA’s role to protect the public based on sound scientific evidence, the letter said.