The Food and Drug Administration (FDA) has approved the Harmony Transcatheter Pulmonary Valve (TPV) System, a non-surgical heart valve to treat patients with native or surgically-repaired right ventricular outflow tract (RVOT).
The device is intended to improve blood flow to the lungs in pediatric and adult patients who have severe pulmonary valve regurgitation to avoid open-heart surgery, which is the current standard of care.
The implantation procedure involves inserting a catheter, with a collapsed Harmony valve on the end, through a vein in the groin or neck and into position in the RVOT. The valve is then released from the catheter; it expands 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 to flow in the correct direction.
The safety and effectiveness of the Harmony TPV was assessed in a prospective, non-randomized, multi-center clinical study, with the device implanted in 70 patients.
Results showed that 100% achieved the primary safety endpoint of no procedure- or device-related death within 30 days following the implant. The primary effectiveness endpoint of no additional surgical or interventional procedures related to the device and acceptable heart blood flow function at 6 months was achieved by 89.2%, among those with evaluable echocardiography data. Study follow-up has been extended to 10 years as part of the post-approval process.
Adverse events during the study included irregular or abnormal heart rhythms (23.9%, including 14.1% ventricular tachycardia), leakage around the valve (8.5%, including 1.4% major leakage), minor bleeding (7.0%), narrowing of the pulmonary valve (4.2%), and movement of the implant (4.2%).
The device is contraindicated for patients with an infection in the heart or elsewhere; patients who cannot tolerate blood-thinning medicines; or patients who have sensitivity to Nitinol.
“The Harmony TPV provides a new treatment option for adult and pediatric patients with certain types of congenital heart disease,” said Bram Zuckerman, MD, 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 their normal activities more quickly.”
For more information visit FDA.gov.
FDA Approves First in the World Device to Treat Patients with Congenital Heart Disease. [press release]. Silver Spring, MD: US Food and Drug Administration; March 26, 2021.