Medtronic Gets FDA Approval for the First Non-Surgical Valve for Patients with Congenital Heart Disease

By MedTech Intelligence Staff

The Harmony Transcatheter Pulmonary Valve is an alternative to open heart surgery.

FDA has approved Medtronic’s Harmony Transcatheter Pulmonary Valve System for patients who have severe pulmonary valve regurgitation, which can occur as a result of congenital heart disease. It is the first non-surgical device in the world to treat pediatric and adult patients with a native or surgically repaired right ventricular outflow tract (RVOT), which is the part of the heart that carries blood out of the right ventricle to the lungs. The valve aims to improve blood flow to the lung without open-heart surgery; the device could also prolong the time until a patient needs this surgery.

“The Harmony TPV provides a new treatment option for adult and pediatric patients with certain types of congenital heart disease,” said Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices at CDRH in an agency release. “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.”

The valve is implanted via a catheter that is inserted through a vein in the groin or neck into the right side of the heart; once released from the catheter, the valve expands on its own and anchors to the RVOT.

“The typical congenital heart disease patient will face a multitude of open-heart surgeries over their lifetime, to continually address issues with their pulmonary valve. Furthermore, congenital heart disease patients require lifelong monitoring, preventive care and specialized treatment all the way from childhood to adulthood,” said Matthew J. Gillespie, M.D., attending interventional cardiologist, co-director of the Pediatric Valve Center and director of the Cardiac Catheterization Laboratory at Children’s Hospital of Philadelphia, and investigator in the Harmony TPV Clinical Study, in a Medtronic news release.

The device has been deemed a breakthrough therapy under FDA’s Breakthrough Device Designation program.

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