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Medtronic, Inc.
Melody(R) Transcatheter Valve Demonstrates Encouraging Results in Study on Patients with Congenital Heart Disease
November 15th, 2009
Clinical trial results published in this week's Journal of the American College of Cardiology (JACC) describe six-month outcomes for patients using the Melody® Transcatheter Pulmonary Valve from Medtronic, Inc. (NYSE: MDT). The valve is implanted through a catheter procedure instead of open-heart surgery in patients with congenital heart disease affecting the function of their pulmonary valve. The first-of-its kind device is currently under review by the U.S. Food and Drug Administration (FDA) for approval of a humanitarian device exemption (HDE), based on evidence of safety and probable benefit for the Melody valve. On July 22, an FDA advisory panel voted...
Source: Medical Letter on the CDC & FDA (2009-11-15)
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