Transcatheter Pulmonary Valve Eliminates Need for Open Heart Surgery


January 25, 2010

The Melody Transcatheter Pulmonary Valve is the first transcatheter valve cleared by the FDA. The device received market clearance in January 2009 under a humanitarian device exemption (HDE).

Delivered through a catheter and eliminating the need for surgery, the Melody valve will benefit children and adults who are born with a malformation of their pulmonary valve. Previously open-heart surgery was the primary option to restore effective blood flow to their lungs. To date, more than 1,100 patients worldwide have received a Melody valve.

In October 2006, the Melody valve received the CE mark clearance in Europe. In the United States under the 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.

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