Dotmed has learned that the U.S. Food and Drug Administration (FDA) voted (12-0) to recommend approval, with conditions, a novel medical device that addresses the effects of a dysfunctional pulmonary valve without opening the chest for surgery. The pulmonary valve connects the heart to the lungs, where blood is enriched with oxygen before being pumped to the rest of the body.
The FDA's Circulatory System Devices Panel recommended conditional approval of a Humanitarian Device Exemption (HDE) for the Melody Transcatheter Pulmonary Valve, by Medtronic, Inc. for the treatment of children and adults with congenital heart disease. The FDA usually follows the recommendations of its expert panels. Devices approved under HDE are intended to serve patient populations of fewer than 4,000 per year in the United States.
"This Melody valve is an enormous breakthrough -- and an enormous relief -- for patients with congenital heart disease," said pediatric cardiologist Dr. William E. Hellenbrand of the New York-Presbyterian Morgan Stanley Children's Hospital and professor of clinical medicine at Columbia University Medical Center. "The device offers the potential to break the cycle of open-heart surgery.... If the FDA follows the advice of its expert panel, physicians and patients will have a powerful new option for these very sick and hard-to-treat patients."
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Transcatheter valve (TCV) technology provides a less invasive means to replace a failing heart valve. It is designed to allow physicians to deliver replacement valves via a catheter through the body's cardiovascular system, eliminating the need to open the chest. TCV technology can thereby delay open-heart surgery for valve replacement. Medtronic is committed to leading the development of TCV technology for all four valves of the heart: aortic, mitral, pulmonic and tricuspid.
The Melody Transcatheter Pulmonary Valve is the first transcatheter heart valve to be approved for commercial use anywhere in the world and the first to be reviewed by an FDA panel. It received Conformite Europeenne (CE) mark, the European regulatory approval, in October 2006, and has been approved for sale in Canada since December 2006. To date, nearly 1,000 patients worldwide have benefited from the Melody Transcatheter Pulmonary Valve. With today's panel recommendation, the device is on track to become the first transcatheter heart valve of any kind to receive FDA approval for use in the United States.
The panel's recommended conditions of approval include a post-approval study, revision of the patient brochure and instructions for use, and implementation of a physician training and education program.