‘A new treatment option’: FDA approves Harmony TPV, says it could delay the need for certain surgeries

Medtronic has received FDA approval for its Harmony transcatheter pulmonary valve (TPV), making it the first nonsurgical heart valve treatment for patients with a native or surgically repaired right ventricular outflow tract (RVOT).

The solution was approved for both pediatric and adult patients. It was designed to treat severe pulmonary valve regurgitation by improving blood flow to the lungs. The FDA noted that the Harmony TPV may also delay the time before patients need open-heart surgery or reduce the number of open-heart surgeries a patient needs over the course of their lifetime.

“The Harmony TPV provides a new treatment option for adult and pediatric patients with certain types of 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 a prepared statement from the agency. “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 solution’s approval was based on a clinical study focused on mortality and hemodynamic function after 30 days and six months.

“The availability of the Harmony TPV will allow a broader range of congenital heart disease patients access to transcatheter technology,” Nina Goodheart, president of Medtronic’s structural heart & aortic business, said in a company statement. “Harmony TPV's novel attributes make it the only non-surgical solution designed to adapt to a wide variety of anatomies for this specific patient population living with congenital heart disease.”

While the Harmony TPV is now available in the United States, it is currently limited to investigational use only in other parts of the world.