Today at the annual scientific sessions of the American Heart Association, the first U.S. clinical trial data on the 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 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 0 percent from a baseline of 30 percent.
Presenter of the data, Dr. Doff McElhinney, pediatric interventional cardiologist at Children's Hospital Boston, commented, "These data are very encouraging. 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."