Medtronic Announces First U.S. Clinical Trial Data on its Melody Transcatheter Valve


November 11, 2008

November 11, 2008 - Today at the annual scientific sessions of the American Heart Association in New Orleans the first U.S. clinical trial data on Medtronic's Melody transcatheter pulmonary valve were presented.

These findings also represent the first U.S. data on transcatheter valves in a population with congenital heart disease and the first reported U.S. data on the use of a transcatheter valve in the pulmonary position. The Melody valve is currently investigational in the U.S.

Data were presented on 66 patients enrolled at centers in Boston, Seattle, New York, Columbus, and Miami. Encouraging from a safety perspective, the company said there was a high acute procedural success rate of 98 percent. At six-months follow up, maintenance of excellent valve competence was demonstrated as was a corresponding, clinically-significant, reduction of more than 18 percent in right ventricular volume. Valve competence was assessed by median pulmonary regurgitation fraction, which was down to zero percent from a baseline of 30 percent.

"These data are very encouraging," said the presenter of the data, Doff McElhinney, M.D., pediatric interventional cardiologist at Children's Hospital Boston. "Young patients with the types of congenital heart disease included in this study frequently require multiple open heart surgeries during the course of a lifetime. The Melody transcatheter valve is designed as a non-surgical alternative that will, at the very least, allow deferment of the next surgical intervention while protecting the heart from the strain of extra work. These multi-center data demonstrate that the Melody valve can be safely implanted with a high rate of procedural success. We have been encouraged by the excellent early function of the Melody valve and by the six-month clinical outcomes, which demonstrate clear improvements in heart size and valve function."

Of the U.S. congenital heart disease patients who require treatment each year for pulmonary valve dysfunction, approximately 1,500 are candidates for valve replacement with the Melody device.

The Melody valve was designed for patients with congenital heart defects who have a surgically-placed conduit between the right ventricle and pulmonary artery. When the valves in these conduits fail, the Melody valve provides a non-surgical means to restore valve function and prolong the life of a conduit, reducing the number of open-heart surgeries these patients require, Medtronic said. Using the Ensemble system, a physician navigates the Melody valve to the heart by threading it through the body's blood vessels, eliminating the need to open the chest, minimizing trauma and offering a quicker recovery than open heart surgery.

Melody, the world's first commercially available transcatheter valve, is available in 60 centers outside the U.S. following Canadian and European approval. Medtronic B.V., a wholly owned subsidiary of Medtronic, Inc., received CE Mark on the Melody Valve and Ensemble System in 2006.

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