FDA panel rejects CorCap heart sleeve device

	Tweet

A U.S. Food and Drug Administration advisory panel on Wednesday urged the agency to reject a new “heart sleeve” surgical device, saying they had not seen enough evidence of benefit for patients with Heart failure.

The panel of experts voted 9-to-4 against approving Minnesota-based Acorn Cardiovascular Inc.’s CorCap, a device already approved in Europe.

The device is a mesh wrap designed to fit around enlarged and weakened hearts often seen in patients with cardiac failure. It’s snug fit acts like a hose, supporting the heart and allowing it to reduce in size.

The company billed CorCap as an additional treatment for patients with worsening Heart failure despite treatment with multiple drugs.

A trial in 300 patients showed that people using the device experienced significant reductions in heart size, a sign cardiologists look for as an indication of improved heart health.

Patients receiving CorCap were also more likely than control patients to avoid later major heart surgery including transplants. Those that got the device had an 11 percent chance of major heart surgery after two years versus a 26 percent chance for controls.

FDA officials said those results might be biased by surgeons less willing to order second surgeries in patients wearing the heart sleeves.

Panelists said they were troubled by the company’s lack of ability to show that the device’s benefits translated to extended life for patients.

Fourteen percent of patients using CorCap died after two years, roughly the same number that died without using the device, according to Acorn.

“I think that there’s promise here, but we have not had a clear demonstration of benefit,” said Dr. John Somberg, a member of the FDA’s Circulatory System Devices Advisory Panel from Rush University in Chicago.

Dr. Robert Califf, a member of the panel from Duke University, said that he voted against approval because Acorn’s data did not make clear which patients might benefit from the sleeve. “It’s an astounding amount of uncertainty,” he said.

Steven Anderson, Acorn’s director of regulatory affairs, said the company will “quickly” enter talks with FDA officials over CorCap data and that he believed the agency “is ultimately going to determine that CorCap is safe and effective.”

Acorn has marketed CorCap on a limited basis since approval in Europe. Less than 340 patients have used the device since approval in the fall of 2000.

The company remains “determined to get this product to market,” Anderson said. 

RELATED STORIES:
Scientists turn skin cells into beating heart muscle   Too many people get angioplasties, study suggests   New Blood Thinner May Lower Chances of Clots in High-Risk Heart Patients: FDA   Heart Damage After Chemo Linked to Stress in Cardiac Cells   What’s good or bad for the heart, may be the same for the brain   Warfarin in Heart Failure   Increased Sudden Cardiac Death Rate Among HIV Patients   Air pollution level changes in Beijing linked with biomarkers of cardiovascular disease   Lack of basic evidence hampering prevention of sudden heart attacks in sport   Blacks Less Likely to Get Help on Scene After Cardiac Arrest: Study   Heart attack patients taken to PCI hospitals first treated faster   Cameron Health’s under-skin ICD safe, effective

Comments

[ + Post Your Own ]

Now you're in the public comment zone. What follows is not Armenian Medical Network's stuff; it comes from other people and we don't vouch for it. A reminder: By using this Web site you agree to accept our Terms of Service. Click here to read the Rules of Engagement.

There are no comments for this entry yet. [ + Comment here + ]