The FDA's Circulatory System Devices Panel has unanimously voted (12-0) to recommend approval with conditions of Medtronic's new medical device that addresses the effects of a dysfunctional pulmonary valve without opening the chest for surgery.
The panel recommended conditional approval of a humanitarian device exemption (HDE) for Medtronic's Melody Transcatheter Pulmonary Valve, for the treatment of children and adults with congenital heart disease, according to the Minneapolis-based Medtronic. Devices approved under HDE are intended to serve patient populations of fewer than 4,000 per year in the United States.
The panel recommended approval conditions, including a post-approval study, revision of the patient brochure and instructions for use and implementation of a physician training and education program.
Melody is the first transcatheter heart valve to be reviewed by an FDA panel. It received CE Mark in October 2006, and has been approved for sale in Canada since December 2006. To date, nearly 1,000 patients worldwide have had Melody implemented.