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 their normal activities more quickly, thus fulfilling an unmet clinical need of many patients with congenital heart disease,” Zuckerman said in a news release.
A physician uses a thin catheter with a collapsed Harmony valve at the end to deliver the device, with the catheter inserted through a vein in the groin or next and run into the right side of the heart and then into the right ventricular outflow tract. Released from the catheter, the Harmony expands on its own and anchors into the RVOT. Once it’s in place, the Harmony valve opens and closes like a door to enable blood to flow in the correct direction.
FDA granted the premarket approval after a prospective, non-randomized, multi-center clinical study in which doctors implanted Harmony valves in 70 patients. There were no procedure- or device-related deaths within 30 days of implantation. More than 89% of the patients with evaluable echocardiography data achieved the effectiveness endpoint — no additional surgical or interventional procedures related to the device and acceptable heart blood flow function at six months.
Researchers observed some adverse events, including 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%).
FDA has extended post-approval follow-up in the study to 10 years.
FDA previously helped potentially speed up Harmony approval through a breakthrough device designation. The device is also part of the U.S.-Japan Medical Device Harmonization by Doing Collaboration.