Medtronic, Inc. (Minneapolis, Minnesota) announced that its Melody® Transcatheter Pulmonary Valve has received U.S. FDA approval under a Humanitarian Device Exemption (HDE).

The Melody valve will benefit children and adults who are born with a malformation of their pulmonary valve. These patients often require open-heart surgery to restore effective blood flow to their lungs. Previously, the only way to repair or replace a failed pulmonary valve conduit was through additional surgeries. To date, more than 1,100 patients worldwide have received a Melody valve.

“The Melody Transcatheter Pulmonary Valve is a significant technological breakthrough and offers a reprieve for many patients with congenital heart disease – many of whom are young and will require several heart surgeries over their lifetime,” said pediatric cardiologist Dr. William E. Hellenbrand of the NewYork-Presbyterian Morgan Stanley Children’s Hospital and Columbia University Medical Center. “The Melody valve gives patients with congenital heart disease a new, non-surgical approach to managing their disease.”

In October 2006, the Melody valve became the first transcatheter valve to receive regulatory approval anywhere in the world when it received the CE (Conformité Européenne) mark. It is now approved by the FDA for use in the United States under an HDE, a special regulatory approval for treatments intended for fewer than 4,000 U.S. patients per year. HDEs are granted for medical devices that have demonstrated reasonable safety and probable benefit, but not clinical effectiveness.

For additional information, go to: http://www.medtronic.com/melody/index.html