Medtronic's Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery System treats patients requiring congenital pulmonary heart valve replacement.
The system is not FDA approved, but has gained Canadian approval and CE Mark approval. Currently, three U.S. hospitals are participating in clinical trials with the device, including Children’s Hospital Boston (Boston, MA), Morgan Stanley Children’s Hospital of NewYork - Presbyterian (New York, NY) and Miami Children’s Hospital (Miami, FL).
Oftentimes, this type of defect requires open-heart surgery early in life to implant a prosthetic or bioprosthetic valved-conduit to establish adequate blood flow from the heart to the lungs. However, the functional life span of these conduits is relatively limited, and as a result, most patients with this type of defect may require multiple open heart surgeries to place new valved conduits as they grow over their lifetime. To meet this clinical need, Medtronic will use this trial to evaluate the Melody valve and Ensemble delivery system as a catheter-based alternative treatment in order to restore effective pulmonary valve function and potentially prolong the functional life of the right ventricle to pulmonary artery conduits. This alternative treatment is designed to reduce the number of open-heart surgeries these patients must undergo.
October 01, 2026 
