FDA: More Study Needed for CorCap
The FDA medical devices dispute resolution panel that met on Dec. 15 voted 3 to 1 to uphold a previous FDA decision that did not approve the CorCap cardiac support device. The agency says the heart device needs more study.
Acorn Cardiovascular Inc. disagreed with the FDA and said it had provided enough information to support a reasonable assurance of safety and effectiveness of its implantable mesh bag designed to support the blood-pumping muscle of patients with heart failure.
The device consists of a polyester mesh bag designed to be surgically wrapped around an enlarged heart to support the organ and potentially reverse the progression of heart failure, according to an AP news report on Yahoo.