Medtronic Harmony TPV’s European Approval Expanded to Treat Congenital Heart Disease

January 6, 2025—Medtronic announced it received CE Mark approval for the Harmony transcatheter pulmonary valve (TPV) system to treat congenital heart disease patients with native or surgically repaired right ventricular outflow tract (RVOT). The device is expected to be commercially available across Europe later this month, advised Medtronic.

The Harmony TPV system, which has already been implanted in > 2,200 patients, now can be used to treat many more patients across the European Union, stated the company.

According to Medtronic, the Harmony TPV system is designed to treat patients with RVOT anomalies with severe pulmonary valve regurgitation.

The device’s clinical trials have demonstrated ease of implantation, conformability to the anatomy, and strong clinical and hemodynamic outcomes for congenital heart disease patients up to 3 years, noted the company.

“Receiving CE Mark for the Harmony TPV system helps advance options for minimally invasive solutions for physicians to treat this vulnerable patient population and optimize their outcomes,” commented Professor Peter Ewert, MD, in Medtronic’s press release.

Prof. Ewert, who is Director of the Department of Congenital Heart Defects and Pediatric Cardiology at the German Heart Center in Munich, Germany, continued, “Clinicians across Europe are in need of solutions to fill this gap, and this milestone will be a potential turning point for patients who want to avoid multiple surgeries and minimize medical disruptions in their daily lives.”

In March 2021, Medtronic announced FDA approval of the Harmony TPV system. The midterm (3-year) data from the Harmony TPV United States trial demonstrated superior patient outcomes with positive sustained RV remodeling, effective valve function, and a strong safety profile, all contributing to significant improvement in patient quality of life, noted Medtronic in the press release.