Novel Transcatheter Heart Valve Alleviates CHD Symptoms

The Harmony is comprised of a porcine pericardium valve, sewn to a polyester-covered asymmetrical hourglass nitinol frame, thus providing natural venous valve leaflets that open and close under minimal pressure for optimal hemodynamics.

Harmony TPV placement is via a transcatheter procedure using a 25 Fr delivery system. During the implantation procedure, a catheter pre-loaded with a collapsed valve is inserted through a vein in the groin or in the neck and into the right side of the heart, and then into the RVOT where it is placed into position. The valve is then released from the catheter; it expands on its own, and anchors to the RVOT. Once the new valve is in place, it opens and closes like a door to force the blood to flow in the correct direction. Deep coaptation of the leaflets provides valve competency across a range of conduit sizes and geometries.

“The Harmony TPV provides a new treatment option for adult and pediatric patients with certain types of congenital heart disease,” said Bram Zuckerman, MD, of the FDA Center for Devices and Radiological Health (CDRH). “It offers a less-invasive treatment alternative to open-heart surgery to patients with a leaky native or surgically-repaired RVOT and may help patients improve their quality of life and return to their normal activities more quickly, thus fulfilling an unmet clinical need of many patients with congenital heart disease.”

TPV is an established method of treating pathologic regurgitation or stenosis of the pulmonary valve, RVOT, or RV-PA due to CHD defects such as Tetralogy of Fallot and pulmonary atresia. But despite excellent long-term survival, patients typically require multiple operative procedures until adulthood, as homograft pulmonary artery conduits or grafts have no ability to grow and remodel with the somatic growth of the child. Additionally, an intense inflammatory reaction to these materials commonly occurs, resulting in early calcification and failure.