FDA approves Medtronic’s Harmony transcatheter pulmonary valve system

FDA has approved a Medtronic device described as a first-in-the-world, non-surgical heart valve to treat severe pulmonary valve regurgitation — a condition often arising from congenital heart disease.

The Harmony transcatheter pulmonary valve system could delay the time before someone with congenital heart disease might need additional open-heart surgery, FDA said today. The Harmony device could also potentially reduce the number of open-heart surgeries needed over a person’s lifetime.

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

“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 …

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