The FDA has approved the first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically repaired right ventricular outflow tract (RVOT). The Harmony Transcatheter Pulmonary Valve (TPV) System, is intended to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation without open-heart surgery—currently the standard of care.

The device is intended for patients who have severe pulmonary valve regurgitation; a condition that often results from congenital heart disease, according to a release from the FDA.

Use of the Harmony valve may delay the time before a patient needs additional open-heart surgery and can potentially reduce the total number of open-heart surgeries required over an individual’s lifetime, according to the FDA.

Congenital heart defects are the most common type of birth defect, affecting about 40,000 babies born each year.

During implantation of a Harmony valve, a thin, hollow tube (catheter) with a collapsed Harmony valve on the end 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 releases from the catheter, expanding 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 flow in the correct direction.

In a prospective, non-randomized, multicenter clinical study, physicians implanted the device in 70 patients. The follow-up has been extended to 10 years as part of the post-approval study.
The primary safety endpoint was no procedure- or device-related death within 30 days following the implant, which 100% of patients attained. 

As for effectiveness, among those with evaluable echocardiography data, 89.2% of them achieved the primary effectiveness endpoint.

“The Harmony TPV provides a new treatment option for adult and pediatric patients with certain types of congenital heart disease. 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,” Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, said in the release.



By MD /alert Staff