On June 22, the Circulatory System Device Panel of the FDA Medical Devices Advisory Committee will review a premarket approval application for the CorCap Cardiac Support Device (CSD), a heart failure therapy developed byAcorn Cardiovascular(St. Paul, Minnesota).

The meeting will include discussion of updated results from the Acorn clinical trial, first presented at the 2004 American Heart Association (Dallas) scientific sessions, which was conducted to evaluate safety and effectiveness of the CorCap CSD.

The CorCap CSD is a mesh wrap that is placed around the heart to stop the unhealthy enlargement of the heart caused by heart failure. It is the first medical device specifically designed to address the problem of cardiac enlargement by providing direct support to the heart, Acorn says. In this way, the CorCap CSD is intended to improve the heart’s structure and function, leading to improvements in the patient’s quality of life.