The The Food and Drug Administration put their seal of approval on a minimally invasive heart valve earlier today. The Melody Pulmonary Valve, made by Medtronic Inc, should be an alternative to open heart surgery for some patients.
The government approval paves the way for development of the device for immediate treatment of some patients with congenital heart defects. The defects, which effect around 4,000 Americans each year, include narrowed, leaky, or missing pulmonary valves that stall blood flow from the heart’s right ventricle to the pulmonary artery, the artery that carries blood to the lungs.
“The FDA’s approval of Melody allows patients to undergo a much less invasive procedure to treat their heart condition,” said Jeffrey Shuren, J.D., M.D., director of the FDA’s Center for Devices and Radiological Health in a release to the media. “Congenital heart defects represent the number one birth defect worldwide and this approval represents a new, first-of-a-kind treatment option for some of those patients.”
Medtronic trades on the New York Stock Exchange. Company shares were up 2.1 percent after the announcement.







