Medtronic Earns CE Mark for Harmony Transcatheter Pulmonary Valve Replacement System

Medtronic has earned CE mark clearance for its Harmony transcatheter pulmonary valve (TPV), a minimally invasive alternative to open-heart surgery for congenital heart disease patients with native or surgically repaired right ventricular outflow tract (RVOT).

Harmony TPV treats patients with RVOT anomalies with severe pulmonary valve regurgitation (PR). Its clinical trials, according to Medtronic, have shown ease of implantation, conformability to anatomy, and strong clinical and hemodynamic outcomes for up to three years.

EU approval follows U.S. Food and Drug Administration (FDA) approval of the Harmony TPV system in 2021.

“The expansion of the Harmony TPV system enables a critical new solution, ensuring that more patients can have access to cutting-edge transcatheter technology and potentially lessen the need for multiple surgeries,” said Nina Goodheart, senior VP and president of Medtronic’s Structural Heart & Aortic business. “This significant milestone underscores our unwavering commitment to delivering minimally invasive treatment options with excellent safety and effectiveness to patients and physicians worldwide.”

Harmony TPV mid-term (three-year) data results demonstrated superior outcomes with positive sustained right ventricular remodeling, effective valve function, and a strong safety profile, the company said. The device is anticipated to roll out across Europe later this month.

“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,” said Professor Peter Ewert, MD, Ph.D., director of the Department of Congenital Heart Defects and Pediatric Cardiology at the German Heart Center in Munich, Germany. “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.”

Last month, Medtronic announced that the University of Miami Health System (UHealth) successfully performed the first-ever procedure ingestion using its next-gen PillCam Genius SB capsule endoscopy kit.