Harmony™ TPV is a new transcatheter valve system that has recently been granted FDA approval for the treatment of severe pulmonary regurgitation in patients with a native or surgically-repaired right ventricular outflow tract (RVOT). This product offers a minimally invasive treatment option for patients who have been diagnosed with severe pulmonary regurgitation and are clinically indicated for surgical pulmonary valve replacement.
The Harmony Transcatheter Pulmonary Valve (TPV) System is intended for use in both pediatric and adult patients. It is designed to be used in the management of severe pulmonary regurgitation, as determined by echocardiography and/or pulmonary regurgitant fraction ≥ 30% as determined by cardiac magnetic resonance imaging.
The company behind the Harmony™ TPV product offers dedicated support and guidance from clinical congenital heart disease (CHD) experts at all stages of the therapy. This includes physician training, patient selection and screening, implant, and post-implant. The company provides multi-step learning opportunities for physicians, a proprietary fit analysis report to assist with patient selection, device selection, and device placement, as well as pre-, intra-, and post-operative support. They also commit to data transparency, long-term data reporting, and enduring patient education.