The Melody™ Transcatheter Pulmonary Valve from Medtronic, a pediatric system for patients with congenital heart defects, specifically those with right ventricular outflow tract (RVOT) conduits, has received the Medical Device License from Health O’Canada.
From the statement by Medtronic:
“This approval marks another significant milestone for this unique transcatheter valve replacement system,” said Oern Stuge, MD, senior vice president and president of the Cardiac Surgery business at Medtronic. “Quite simply, this system is designed to reduce the number of times that certain patients may need to undergo open heart surgery by providing a minimally invasive, catheter-based solution to valve replacement. Medtronic remains committed to our pioneering work in structural heart disease, and we are pleased that patients in Canada will now be able to benefit from this less invasive approach to valve replacement.”
The Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery System are designed to benefit patients with congenital heart defects involving the connection between their right ventricle and pulmonary artery. Oftentimes, this type of defect requires open heart surgery early in life to implant a prosthetic 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 are committed to multiple open heart surgeries over their lifetime. The Melody valve and Ensemble system provide a non-surgical means to restore effective valve function and prolong the functional life of prosthetic conduits, thereby reducing the number of open heart surgeries for these patients throughout their lifetime.