Melody, Medtronic's transcatheter pulmonary valve has gained FDA approval under a Humanitarian Device Exemption (HDE) for its use in patients with congenital heart disease.
The Melody will benifit adults and children who have a malformation of the pulmonary valve. Typically, these patients require multiple surgeries or open-heart surgery to repair or replace a failed pulmonary valve to restore blood flow to the lungs. Melody uses a non-surgical approach and is delivered via catheter, requiring only a small incision, according to the Minneapolis-based company.
The Melody valve is the first transcatheter heart valve to gain FDA approval. In October 2006, the device was awarded CE Mark of approval and has been used in 1,100 patients.
HDE is a regulatory approval for treatments intended for fewer than 4,000 U.S. patients per year.