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 unanimously to recommend conditional approval of the Melody valve, but the device remains investigational in the United States until FDA makes a final decision.
“The Melody transcatheter valve is a viable procedural alternative designed to reduce the number of invasive surgeries and their associated risks,” said Dr. Evan Zahn, director of cardiology at Miami Children’s Hospital’s Congenital Heart Institute and lead author of the published study. “It represents an exciting breakthrough for individuals who typically require numerous open-heart surgeries during the course of their lifetime.”
The study is the first prospective, multi-center trial conducted to evaluate the implantation of the Melody valve. The JACC article reports procedural success in 97 percent of patients; encouraging immediate and six-month patient outcomes with improvements in heart and valve function; and overall acceptable study safety outcomes with no deaths or long-term procedure-related medical complications.