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Medtronic's Harmony transcatheter pulmonary valve (TPV) was approved Friday for treatment of severe pulmonary valve regurgitation with a native or surgically repaired right ventricular outflow tract (RVOT).

This clears TPV implantation, a less invasive alternative to open-heart surgery, for people who have undergone RVOT surgery for congenital heart defects (CHDs) but have not received a prior valve or right ventricle-pulmonary artery (RV-PA) conduit.

Placement of the Harmony may delay the time before a patient needs additional open-heart surgery and reduce the total number of surgeries required over a person's lifetime.

The Harmony "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," said the FDA's Bram Zuckerman, MD, in a .

Melody, a different TPV also from Medtronic, has been on the market since 2010 and is indicated for implantation within an existing dysfunctional RV-PA conduit or bioprosthetic pulmonary valve.

FDA approved the Harmony after reviewing data from 70 people in a , the preliminary results of which were reported last year.

The study reached its primary safety endpoint, as there were no procedure- or device-related deaths within 30 days following valve placement. The primary effectiveness endpoint was met as well, with 89.2% of people with evaluable echocardiography requiring no additional procedures related to the device and acceptable heart blood flow function at 6 months.

Adverse events reported included arrhythmias (23.9%), leakage around the valve (8.5%), minor bleeding (7.0%), narrowing of the pulmonary valve (4.2%), and movement of the implant (4.2%).

Labeling for the Harmony notes that it is contraindicated for patients with an infection, people who cannot tolerate blood thinning medicines, and those who are sensitive to Nitinol (titanium or nickel).

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