Medtronic (NYSE: MDT) today announced the results of two successful clinical trials for its transcatheter pulmonary valve (TPV) therapies Melody and Harmony.
The Fridley, Minnesota-based medical tech giant virtually presented its 10-year results at the 2020 Society for Cardiovascular Angiography & Interventions (SCAI) science sessions. Melody demonstrated strong hemodynamic and long-term safety results, while the pivotal investigational Harmony TPV trial met the safety and efficacy endpoints for hemodynamic function at six months, according to a release from hurry.
Melody TPV has demonstrated constant hemodynamics for 10 years with high valve efficiency with 97% pulmonary failure / trace / mild pulmonary regurgitation. The annualized incidence of TPV-related endocarditis was 2% per patient-year, while no major stent fracture was 84% at 10 years and no reoperation was 61%.
This study included 150 implanted patients aged 7 to 53 years, with a median age of 19 years and the main indication for intervention being pulmonary regurgitation.
Medtronic is promoting the Melody Transcatheter Valve as the first of its kind to be implanted in humans anywhere in the world and to achieve FDA approval. In 2017, it won an expanded indication for implantation in patients with failed surgical bioprosthetic pulmonary heart valves, making it the first TPV to achieve this indication.
“Having long-term data is an important step, especially for this pediatric patient population that grows and changes so rapidly over a ten-year period,” said Seattle Children’s director of cardiac catheterization. , Dr. Thomas Jones. “Although the study enhances the longevity, durability and efficacy of Melody TPV, it will also serve as a study model for future evaluations of new pediatric congenital heart disease technologies. “
Harmony TPV results revealed that 100% of patients experienced no procedure or device-related mortality at 30 days and that acceptable hemodynamic function at six months was observed in 89% of participants in the test, exceeding the performance target by 75%.
At six months, 94% of patients had no or mild pulmonary regurgitation and 97% had no or slight paravalvular leakage, the statement said.
The trial included 50 patients at 12 sites in the United States, Canada and Japan. Harmony TPV is designed for patients with right ventricular outflow tract (RVOT) abnormalities who develop severe pulmonary regurgitation when a previous repair fails. It is not yet approved for anything other than experimental use in the United States.
“As these latest studies show, we are constantly building our body of new, short and long term research around innovative and minimally invasive TPV solutions for patients with coronary artery disease,” said Sandra Lesenfants, Vice President and Director General of the Structural Heart Division of Medtronic. said in the press release. “This Harmony data demonstrates our commitment to generating new therapies and expanding our Congenital Heart Disease program to support a lifetime of care this patient population needs. “