FDAnews
www.fdanews.com/articles/73595-fda-panel-rejects-corcap-heart-sleeve-device

FDA PANEL REJECTS CORCAP 'HEART SLEEVE' DEVICE

June 23, 2005

The FDA's Circulatory System Device panel recommended the agency reject a new "heart sleeve" surgical device, saying there was not enough evidence of benefit for patients with heart failure.

The panel of experts voted 9-4 against approving St. Paul, Minn.-based Acorn Cardiovascular's CorCap Cardiac Support Device, a mesh wrap designed to fit around enlarged and weakened hearts, supporting the heart and allowing it to reduce in size.

While a 300-patient trial showed that people using the device experienced sustained improvements in heart size, heart shape and quality of life, panel members said they were troubled by the company's lack of ability to show the device's benefits translated to extended life for patients. The company plans to work with the FDA regarding next steps toward approval.