FDA approves nonsurgical heart valve to treat congenital heart disease
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The FDA announced it approved a self-expanding nonsurgical heart valve for pediatric and adult patients with a native or surgically repaired right ventricular outflow tract.
According to the release, the new transcatheter pulmonary valve system (Harmony TPV, Medtronic) is designed for patients with severe pulmonary valve regurgitation often associated with congenital heart disease.
The device is intended to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation without open-heart surgery.
“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 RV outflow tract 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 of the FDA’s Center for Devices and Radiological Health, said in the release.
The FDA assessed the efficacy and safety of the nonsurgical heart valve through a prospective, nonrandomized, multicenter clinical study in which the device was implanted in 70 patients. Participants are being followed up for 10 years as part of a postapproval study. The primary safety endpoint was no procedure- or device-related death within 30 days following implantation, which was achieved in 100% of the cohort. The primary effectiveness endpoint was percentage of patients with no additional surgical or interventional procedures related to the device and acceptable heart blood flow function at 6 months.
Among participants with evaluable echocardiography data, 89.2% achieved the primary effectiveness endpoint. Adverse events included irregular or abnormal heart rhythms (23.9%), leakage around the valve (8.5%), minor bleeding (7%), narrowing of the pulmonary valve (4.2%) and movement of the implant (4.2%).
According to the release, the new system is contraindicated for patients with an infection in the heart or elsewhere; patients who cannot tolerate blood thinning medicines; or those who have sensitivity to nitinol (titanium or nickel).
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