Medtronic has announced two-year results for its Harmony transcatheter pulmonary valve (TPV) system, which treats severe pulmonary regurgitation (PR) in the native or surgically repaired right ventricular outflow tract (RVOT).
The analysis demonstrates strong clinical and haemodynamic outcomes for patients with a congenital heart defect of the RVOT and was presented at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 scientific sessions (18–20 May, Phoenix, USA).
“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,” Mary Hunt Martin (University of Utah and Primary Children’s Hospital, Salt Lake, USA). “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.”
Harmony TPV was 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. The Harmony TPV provides these patients with a minimally invasive treatment alternative.
Patients received a commercially available Harmony valve—a 22mm valve (TPV22 device) or a 25mm valve (TPV25 device)—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 ≥30% by cardiac magnetic resonance imaging and a clinical indication for pulmonary valve replacement. In the study, 86 patients were implanted with a TPV22 (n=42) or TPV25 (n=44) device, all of whom remained implanted for >24 hours.
Key findings include 0% vascular injury requiring intervention, 99% freedom from major stent fracture, and 99% with no/trace PR at two years.
The Harmony TPV System received US Food and Drug Administration (FDA) approval in 2021 based on the Harmony TPV clinical study that demonstrated safety and effectiveness.
The Harmony TPV device is commercially available for use in the United States and Japan, and has received regulatory approval in Canada and Saudi Arabia.
Earlier this year, Medtronic relaunched the Harmony TPV system following a voluntary recall of the Harmony Delivery Catheter System (DCS) in March 2022. Medtronic worked collaboratively with the FDA to remediate the issue and earn FDA approval to return the device to market.