The Harmony Valve study is for patients in need of pulmonary valve replacement. The HarmonyTM Valve is a transcatheter pulmonary valve specifically designed for patients in need of a pulmonary valve replacement who do not want to have to undergo surgery. Surgical placement of a new valve is the most common treatment for a nonworking pulmonary valve, however, there are many risks associated with open heart surgery and it is followed by months of recovery. A less invasive approach for treatment is now available by placement of a pulmonary valve by a transcatheter procedure. The HarmonyTM Valve has not been approved by the FDA yet for commercial use and is only available by participating in the study.
Please contact Dr. Matthew Gillespie (firstname.lastname@example.org) if you or your patient may be interested in participating in the trial of this device.