Medtronic's Harmony pulmonary valve wins FDA approval.
FDA on Friday said it approved Medtronic's catheter-based treatment for pediatric and adult patients with severe pulmonary valve regurgitation in the right ventricular outflow tract, which carries blood from the heart to the lungs.
The Harmony transcatheter pulmonary valve offers a less-invasive treatment alternative to open-heart surgery for patients with the condition, which typically is the result of a congenital heart defect. FDA said the Medtronic device is the first non-surgical valve approved to treat these patients.
The Harmony valve was granted FDA premarket approval after receiving the agency's breakthrough device designation to expedite its development. Approval was based on a 70-patient clinical study in which all patients achieved the primary safety endpoint of no death within 30 days of implant and 89.2% of patients with echocardiography data met the primary effectiveness endpoint of no additional procedures related to the device plus acceptable blood flow at six months.
Medtronic along with Edwards Lifesciences are the dominant players in the steadily growing market for transcatheter aortic valve replacement, or TAVR, which surpassed surgery in the U.S. in 2019 as the primary approach for treating faulty aortic valves. The companies' efforts to develop minimally invasive treatments to rival Abbott's lead in the mitral valve space are also being closely watched.
New approaches to treating pulmonary valve disease have received less attention, but Medtronic has been working in this area for more than a decade, starting with the development of its Melody transcatheter valve replacement, which is approved for patients with a dysfunctional right ventricular outflow tract conduit. The Harmony device is a self-expanding transcatheter valve, while Melody is a balloon-expandable valve.
Edwards is also eyeing the pulmonary valve market and gained FDA approval last year for an expanded indication for its Sapien 3 transcatheter heart valve for use in patients with a dysfunctional right ventricular outflow tract conduit or a dysfunctional bioprosthetic valve in the pulmonic position.
Open-heart surgery is the current standard of care for improving blood flow to the lungs in patients with pulmonary valve regurgitation, in which blood leaks backward into the heart. A patient with congenital heart disease may face multiple open-heart surgeries to address issues with the pulmonary valve. FDA said use of Medtronic's Harmony valve may help patients delay or reduce the number of repeat open-heart surgeries needed over a lifetime to address the condition.
"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, FDA's director of the office of cardiovascular diseases, said in a statement.
The Harmony device is implanted via a catheter through a vein in the groin or neck. The collapsed valve is released in the right ventricular outflow tract, where it expands on its own. FDA said the follow-up period for observing patients who received Medtronic's Harmony valve has been extended to 10 years from five years as part of the post-approval study.
Like other big medical device makers, Medtronic has been contending with another slowdown in procedures that hit late last year and carried into the new year, following the initial pandemic-related pullback and subsequent rebound from pent-up demand. CEO Geoff Martha last month predicted a return to growth is on the way but stopped short of providing a near-term financial outlook.