Medical Professional Publications

In a Pivotal Clinical Trial, the First Implantation of a Medtronic Harmony™ Transcatheter Pulmonary Valve

Columbus, OH — June 2017

Children born with an abnormality of the right ventricular outflow tract require open surgery to correct it. Approximately 77 percent of those patients receive valve replacement – and when the replaced valve fails, another open-heart surgery is required.

A possible minimally-invasive alternative to that second surgery, the Medtronic Harmony™ Transcatheter Pulmonary Valve, is now in clinical trial. The first implantation of the valve occurred this spring at Nationwide Children’s Hospital.

The trial comes on the heels of a first-of-its-kind feasibility study, reported on last year. Among the 18 patients with a Harmony valve who were followed six months after implantation, severe pulmonary regurgitation dramatically improved and mean right ventricular outflow tract gradients were stable.

“We are honored to be the first site to implant this device, both in the past Early Feasibility Study and now as part of this pivotal clinical trial,” says John P. Cheatham, MD, co-director of The Heart Center at Nationwide Children’s and principal investigator for the Harmony valve.

The Harmony valve therapy builds on technology for Medtronic Melody™ Transcatheter Pulmonary Valve, which has been implanted in more than 10,000 patients worldwide. The Melody valve was designed for patients with a failing right-ventricular-to-pulmonary-artery-valved conduit, which accounts for about 23% of the right ventricular outflow patient population. The Harmony valve could be an alternative for the rest of the patients.

Dr. Cheatham, who is also a professor of Pediatrics and Internal Medicine at The Ohio State University College of Medicine, was involved in the design and testing of the stent for the Melody valve as well as the valve’s delivery balloon.

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