Replacement Heart-Conduit Valve Implanted Without Surgery

The Melody TPV is delivered through a catheter requiring only a small incision, and should benefit children and adults born with a malformation of the pulmonary valve. Deep coaptation of the Melody TPV leaflets provides valve competency across a range of diameters and geometries, and natural venous valve leaflets open and close under minimal pressure for optimal hemodynamics. Sutures at every node of the TPV are designed to enhance valve integrity. The Melody TPV is delivered via the Ensemble transcatheter delivery system, using fluoroscopic guidance. The 22 French delivery catheter offers a low crossing profile, and a balloon-in-balloon deployment enables minor adjustments to facilitate accurate placement. A unique coverage sheath protects the valve during delivery up to the point of deployment.

Similar to other conduits, the Melody TPV does not cure the heart condition and over time may wear and require replacement. But since it is implanted without open heart surgery, it can prop open the poorly functioning conduit and can keep blood flowing in the proper direction, which will allow a patient's conduit to function longer than usual, delaying the need for more invasive open-heart surgery. The Melody TPV and the Ensemble delivery system are products of Medtronic (Minneapolis, MN, USA), and have received U.S. Food and Drug Administration (FDA) approval under a Humanitarian Device Exemption (HDE).

"The Melody Transcatheter Pulmonary Valve is a significant technological breakthrough and offers a reprieve for many patients with congenital heart disease – many of whom are young and will require several heart surgeries over their lifetime,” said pediatric cardiologist William Hellenbrand, M.D., of Columbia University Medical Center (New York, NY, USA). "The Melody valve gives patients with congenital heart disease a new, nonsurgical approach to managing their disease.”

Conduits are surgically implanted valves used to treat patients with congenital heart defects that have narrowed, leaky, or missing pulmonary valves that impede the proper flow of blood from the heart's right ventricle to the pulmonary artery, which then sends the blood on to the lungs for oxygenation.

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