Medtronic’s Harmony Transcatheter Pulmonary Valves to Treat RVOT Evaluated in 5-Year Data

June 4, 2026—Medtronic announced new data on 5-year outcomes with the company’s FDA-approved Harmony transcatheter pulmonary valve (TPV) for treatment of native or surgically repaired right ventricular outflow tract in patients with severe pulmonary regurgitation.

Doff McElhinney, MD, presented the findings at the CSI Frankfurt 2026 meeting.

According to Medtronic, the data, which include patients treated with the commercially available Harmony TPV22 and TPV25 devices, provide insight into midterm durability, safety, and patient-reported outcomes.

Medtronic outlined the key findings at 5 years, which included the following:

• Sustained valve performance was demonstrated with none/trace or mild pulmonary regurgitation in approximately 93% of TPV22 patients and approximately 96% of TPV25 patients.
• There were no new reinterventions reported between years 4 and 5; additionally, freedom from surgical reintervention in TPV25 patients was 100%.
• A stable safety profile was shown with no device- or procedure-related mortality and no new ventricular tachycardia events beyond 30 days.
• Right ventricular remodeling and quality-of-life data showed reductions in volumes and sustained improvements in patient-reported outcomes over time.