April 30, 2021 – SCAI 2021 Scientific Sessions: Investigators unveiled one-year outcomes of the Harmony™ Transcatheter Pulmonary Valve (TPV) Pivotal Trial and 30-Day Outcomes from the Continued Access Study at a late-breaking session during SCAI Scientific Sessions. The recently FDA approved Harmony TPV is the first non-surgical treatment alternative for patients with severe pulmonary regurgitation who have a native or surgically-repaired right ventricular outflow tract.
The results demonstrate the safety and effectiveness of the Harmony TPV system to treat patients with a specific type of congenital heart defect of the right ventricle (RV) with a minimally invasive therapy.
Key findings at 1 year include:
- No instances of explants, endocarditis, major stent fractures, or death
- Only two patients required catheter reinterventions; one patient received a valve-in-valve and one patient received balloon angioplasty
- More than 90% of patients with none/trace pulmonary regurgitation (PR) at all follow-up visits
- Several patients had stable ventricular tachycardia after implant that resolved and did not appear to be clinically important
About the Harmony TPV Clinical Trial
The Harmony TPV Clinical Trial is a prospective, non-randomized, multicenter study designed to evaluate the safety and effectiveness of the Harmony TPV system, conducted at 12 sites in the United States, Canada, and Japan. Primary safety and effectiveness endpoints included freedom from procedure or device-related mortality at 30 days and percentage of patients with acceptable hemodynamic function at 6 months and no Harmony valve intervention.
About Harmony TPV
Harmony™ Transcatheter Pulmonary Valve is the first minimally invasive alternative for patients with severe pulmonary regurgitation who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement. Harmony TPV is designed to delay patients’ need for open heart surgery by restoring pulmonary valve function with a minimally invasive procedure. The valve is made with porcine pericardial tissue and a polyester cloth covering mounted on a self-expanding nitinol frame which conforms to the native RVOT anatomy. The valve re-establishes efficient blood flow from the right ventricle to the lungs where blood is re-oxygenated and then carried to the rest of the body. Harmony TPV is available in two sizes to treat a variety of patient anatomies. The Harmony Delivery Catheter System is used to deliver both valve sizes.