The Melody™ Transcatheter Pulmonary Valve from Medtronic has received Europe’s CE Mark of approval. Indicated for pediatric patients with congenital heart defects, primarily those with right ventricular outflow tract (RVOT) conduits, the system is “the first of its kind worldwide to treat congenital patients with structural heart disease requiring pulmonary heart valve replacement.”
The Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery System is 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.
Medtronic has partnered with Professor Philipp Bonhoeffer, professor and chief of cardiology and director of the Catheterization Laboratory, Great Ormond Street Hospital for Children (GOSH) in London, and NuMed, a pediatric catheter company in the development of the Melody Valve and Ensemble System. A pioneer in transcatheter valve technology, Professor Bonhoeffer implanted the world’s first transcatheter valve in September 2000. To date, more than 150 patients worldwide have been implanted with the Melody Transcatheter Pulmonary Valve.
Transcatheter valve technology represents a less invasive means to treat heart valve disease and is designed to allow physicians to deliver replacement valves via a catheter through the body’s cardiovascular system, thus eliminating the need to open the chest. Traditionally, open heart surgery has been required to correct the problem and it is not unusual for a patient to undergo multiple, open-heart surgeries during their lifetime. Patients with this condition tire very easily, as the heart over-exerts itself trying to get oxygenated blood throughout the body.