FDA Approves Medtronic’s Harmony TPV for Congenital Heart Disease

The U.S. Food and Drug Administration approved Medtronic’s Harmony Transcatheter Pulmonary Valve (TPV) System, which is intended to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation without open-heart surgery. The non-surgical heart valve treats pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT). It’s designed for patients with severe pulmonary valve, a condition that often results from congenital heart disease. Using the Harmony valve may delay the time before a patient needs additional open-heart surgery. It can also potentially reduce the total number of open-heart surgeries required over a lifetime.
 
“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 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,” Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health told the press.
 
Patients with congenital heart defects often require heart procedures early in life to help improve blood flow to the lungs. Afterward, the patient may or may not have a working pulmonary valve, which could lead to pulmonary regurgitation. Severe pulmonary valve regurgitation may be corrected through open-heart surgery to place a right ventricle-pulmonary artery conduit or an artificial valve.
 
During Harmony valve implantation, a catheter with a collapsed Harmony valve on the end is inserted through a vein in the groin or in the neck and into the right side of the heart, then into the RVOT where it is placed into position. The valve is then released, it self-expands, and anchors to the RVOT. Once in place, it opens and closes like a door to force blood to flow in the correct direction.
 
During the Harmony TPV’s clinical study, physicians implanted the device in 70 patients. All were scheduled for follow-up examinations at the study’s start, at implant procedure, discharge, and post implant at one month, six months, and annually through five years. The follow-up was extended to 10 years as part of the post-approval study. The primary safety endpoint was no procedure- or device-related death within 30 days following the implant, which all patients attained. 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 six months. Among patients with evaluable echocardiography data, 89.2 percent of them achieved the primary effectiveness endpoint.
 
Adverse events observed during the clinical study included irregular or abnormal heart rhythms (23.9 percent, including 14.1 percent ventricular tachycardia), leakage around the valve (8.5 percent, including 1.4 percent major leakage), minor bleeding (7.0 percent), narrowing of the pulmonary valve (4.2 percent), and movement of the implant (4.2 percent).
The Harmony TPV 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 (titanium or nickel).
 
The Harmony TPV device was granted Breakthrough Device Designation for the treatment of pediatric and adult patients with severe pulmonary valve regurgitation.
 
The device was also part of the U.S.-Japan Medical Device Harmonization by Doing Collaboration, which seeks to promote timely access to innovative devices in both the U.S. and Japan through greater collaboration and communication among regulatory, academic and industry stakeholders across all stages of product development, and by developing practical solutions to shared real-world challenges.