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www.fdanews.com/articles/169838-medtronics-melody-transcatheter-pulmonary-valve-wins-fda-nod

Medtronic’s Melody Transcatheter Pulmonary Valve Wins FDA Nod

February 4, 2015

Medtronic said Tuesday that the FDA approved its Melody transcatheter pulmonary valve following strong clinical evidence demonstrating the valve’s effectiveness in delaying open-heart reoperation. The device has been available under a humanitarian device exemption since 2010.

The approval was based on results in 310 patients in three clinical studies — the Melody U.S. IDE Study, Melody U.S. Post Approval Study and Melody European and Canadian Post-Market Surveillance Study. Ninety-eight percent of patients were free from open-heart surgery one year after receiving the valve, and 91 percent patients in the IDE study had not required reoperation at five years, Medtronic said.

Congenital heart defects are the most common birth defect in the U.S., affecting 40,000 babies each year. Twenty percent will have deformities that disrupt the blood flow from their right ventricular outflow tract to the pulmonary arteries, and most will receive a connecting conduit to improve that blood flow, Medtronic said. If the conduit fails later in life and the patient hasn’t outgrown it, then a Melody TPV can be implanted to help delay surgical pulmonic valve replacement — a much more invasive procedure.

More than 7,300 patients have received the Melody therapy, more than half of them children, Medtronic said. — Kellen Owings