Medtronic (NYSE:MDT) announced positive two-year results for a study of its Harmony transcatheter pulmonary valve (TPV) system.
Harmony treats severe pulmonary regurgitation (PR) in the native or surgically repaired right ventricular outflow tract (RVOT). The Medtronic analysis demonstrates strong clinical and hemodynamic outcomes for patients with a congenital heart defect of the RVOT. The current standard of care is either open-heart surgery or other interventions early in life to address malformations. Harmony TVP provides a minimally invasive treatment alternative.
Medtronic presented results at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Sessions.
“Sharing these longer-term outcomes for the Harmony transcatheter valve is an important milestone to help offer more streamlined treatment options for patients living with congenital heart disease,” said Dr. Mary Hunt Martin, director of adult congenital intervention at the University of Utah and Primary Children’s Hospital in Salt Lake City. “The strong safety profile reflected in these findings is especially encouraging since prior to Harmony, many of these patients would have to undergo multiple surgeries early on in their life.”
The non-surgical heart valve first received FDA clearance in March 2021. However, in April 2022, FDA designated a Class I recall for the system. Medtronic recalled the system because of issues with the delivery catheter. The bond holding the capsule at the end of the delivery catheter could break during TPV placement, the company found.
Medtronic relaunched Harmony in February of this year.
The data supporting the Medtronic Harmony valve
Patients received a commercially available 22mm (TPV22) or 25mm (TPV25) Harmony valve as part of the Harmony Native Outflow Tract Early Feasibility Study (EFS), Harmony TPV Pivotal Trial, and Continued Access Study (CAS).
Eligible patients had severe PR by echocardiography or PR fraction greater than or equal to 30% by cardiac MRI and a clinical indication for pulmonary valve replacement. In the study, 86 patients received a TPV22 (42) or TPV 25 (44). All remained implanted for more than 24 hours.
Key findings included 0% vascular injury requiring intervention and 99% freedom from major stent fracture. Medtronic also reported 99% of patients with no/trace PR at two years.
“These findings help deepen our long-term evidence for Harmony TPV and underscore our commitment to providing solutions for congenital patients with complex anatomies,” said Nina Goodheart, SVP and president of the Structural Heart & Aortic business at Medtronic. “Providing a system designed to reliably treat pulmonary regurgitation is an important way Medtronic innovations positively impacts this vulnerable patient population.”