Medtronic's Harmony Transcatheter Pulmonary Valve Replacement System Receives CE Mark Approval

Medtronic's self-expanding Harmony Transcatheter Pulmonary Valve Replacement (TPVR) System has received CE Mark approval, meaning the device can now be sold and marketed throughout the European Union.

Harmony TPVR System Previously Received Approval in 2021U.S. Food and Drug Administration (FDA)Approval for the treatment of children and adult patients with severe pulmonary regurgitation (PR) who have autologous leakage or surgically repaired right ventricular outflow tracts (RVOT). Due to durability issues, Medtronic did initiate a program in 2022.Voluntary Recall, but in less than a yearRelaunched the device。

"The expansion of the Harmony TPV system introduces a critical new solution, ensuring more patients have access to cutting-edge transcatheter technology and potentially reducing the need for multiple surgeries," said a senior vice president of Medtronic and president of the Structural Heart and Aortic business.Nina GoodheartIn aStatementThis important milestone highlights our unwavering commitment to providing minimally invasive treatment options with superior safety and efficacy for patients and doctors worldwide.

"The Harmony TPV system receiving the CE mark helps provide doctors with a minimally invasive solution option to treat these fragile patient populations and optimize their outcomes," said the Director of the Department of Congenital Heart Defects and Pediatric Cardiology at the German Heart Center Munich, Germany.Peter EwertDr. added, "Clinicians in Europe need solutions to fill this gap. This milestone could be a potential turning point for patients who wish to avoid multiple surgeries and minimize medical disruptions in their daily lives."

According to a recent publication inJournal of the American College of CardiologyOne ItemAnalysisThe self-expanding TPVR system was found to be both safe and effective over a year later. The study includes data from 243 real-world patients treated in the U.S. as of April 2022. The median age of the patients was 31 years, with the youngest patient being 8 years old at the time of the procedure.

At 1 year, 99% of patients and at 2 years, 96% of patients were free from the composite clinical outcome — hemodynamic dysfunction and/or RVOT re-intervention.

Harmony™ Transcatheter Pulmonary Valve (TPV) is the first FDA-approved transcatheter valve system specifically designed to treat severe pulmonary regurgitation in patients with native or surgically repaired right ventricular outflow tract (RVOT). This valve offers a minimally invasive treatment option for your patients.

Overview of the Harmony Valve System

Harmony™ Transcatheter Pulmonary Valve is designed for native RVOT.

• Full Sheath Delivery System

• This delivery system offers excellent traceability through the vascular system.1

• Self-expanding Nitinol Frame

Harmony™ TPV consists of a self-expanding nitinol frame, which is composed of individual wire struts designed to conform to the native RVOT anatomy.

• Pericardial Valve Leaflets

Porcine pericardial valve leaflets provide excellent kinematics across the entire pressure range of the right heart.

• The valve and stent are integrated together, providing a one-step delivery process for predictable device deployment at the intended location.

• Porcine Pericardial Tissue Valve

• Self-expanding Nitinol Frame

• Polyester Cloth Covering

• A variety of valve sizes with different inflow diameters, outflow diameters, and lengths to accommodate various patient anatomies.

Harmony™ Delivery Catheter System

•  The loading system helps simplify the valve loading process.

• Load the loading funnel into the compressed valve before the sheath.

• Retractable Sheath

• An ergonomic handle facilitates pulling and releasing the valve during final deployment.