Advisory panel rejected CorCap Cardiac Support Device

The surgically implanted mesh device is designed to improve cardiac structure in heart failure patients.

GAITHERSBURG, Md. — A Food and Drug Administration advisory panel voted 9-4 not to recommend approval of the CorCap Cardiac Support Device for patients with heart failure.

Advisory panel votes are not regulatory decisions, but the FDA often follows a panel’s advice.

Representatives from Acorn Cardiovascular presented data on the CorCap Cardiac Support Device that suggested it would enhance quality of life and improve cardiac structure for patients with heart failure without increased mortality or other adverse events.

“Although there is clearly some very early biologic effect, I don’t see the clinical effectiveness given the data we have,” said panel member Eugene H. Blackstone, MD, at the Cleveland Clinic. “Because there is some increased risk here as well, documented in the CorCap alone group and by dense adhesions that make reoperation difficult and later coronary artery bypass grafting near impossible, the clinical effectiveness is not high enough to outweigh risk.”

Jeffrey Borer, MD, was a member of the Food and Drug Administration advisory panel for the CorCap Cardiac Support Device.

Panel members who voted in favor of the approval said the device would be effective enough in a small group of patients, already maximally treated with available heart failure therapies, to alleviate concerns about safety.

“It’s a shame to deny this therapy to a small subset of patients that don’t have any other options,” said panel member Thomas A. Vassiliades, MD, Emory University.

Representatives from Acorn Cardiovascular said the company would continue to work with the FDA toward approval of the device.

CorCap

The CorCap Cardiac Support Device is a mesh wrap that is implanted around the heart to prevent and reverse the progression of heart failure by improving the heart’s structure and function.

CorCap Cardiac Support Device Courtesy of Acorn Cardiovascular.

In support of its application, Acorn Cardiovascular presented a trial of 300 patients who had NYHA Class III-IV HF and dilated cardiomyopathy. Patients indicated for mitral valve repair or replacement (n=193) were randomized to either mitral valve surgery alone or mitral valve surgery and the CorCap device. The remaining 107 patients were randomized to continued optimal medical therapy or optimal medical therapy plus the CorCap device.

After a median follow-up of 22 months, researchers assessed a primary composite outcome of all-cause mortality, NYHA class and major cardiac procedures indicative of heart failure. The group treated with the CorCap device had more patients classified as improved (38% vs. 27%) and fewer patients classified as worsened (37% vs. 45%), which was a statistically significant difference (P=.02).

“I hear the 38% number, but compared to a control group with 27% that’s not especially compelling,” said panel member Richard Page, MD, University of Washington.

Panel members said it was even less compelling in light of the mortality rates.

“In general, just looking at risk stratification for cardiac operations, a redo doubles the mortality risk,” said panel member Norman S. Kato, MD, of the Cardiac Care Medical Group in Encino, Calif. “In the trial we’ve been asked to review, we’re dealing with obviously talented physicians. I just wonder about later. If the device goes to market, we might see an increased mortality risk.”

Survival rates were not different between the two groups at two years at 84% in the treatment group and 83% in the control group.

“We need to remember for whom this therapy is intended. These are very sick people. I think that this technique holds promise for improving quality of life. No one has suggested it improves length of life,” said panel member Jeffrey Borer, MD, Weill Medical College of Cornell University. – by Jeremy Moore