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Article: Melody[R] Transcatheter Valve Demonstrates Encouraging Results in Study on Patients with Congenital Heart Disease.
- Article from:
- Medical Devices & Surgical Technology Week
- Article date:
- November 15, 2009
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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[R] 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 (see also Medtronic, Inc.).
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 ...