Harmony Transcatheter Pulmonary Valve system approval expands minimally invasive treatment options for patients with congenital heart disease across European Union

Medtronic plc, a global leader in healthcare technology, today announced it received CE (Conformité Européenne) Mark for the Harmony Transcatheter Pulmonary Valve (TPV) System, a minimally invasive alternative to open-heart surgery for congenital heart disease patients with native or surgically repaired right ventricular outflow tract (RVOT). The Harmony TPV system has already been implanted in over 2,200 patients and now has access to help many more patients across the European Union.

The Harmony TPV system is designed to treat patients with RVOT anomalies with severe pulmonary valve regurgitation (PR), a condition where blood leaks back into the right lower chamber of the heart after being pumped into the lungs. Harmony TPV system clinical trials demonstrate ease of implant, conformability to the anatomy, and strong clinical and hemodynamic outcomes for congenital heart disease patients up to three years.