Harmony™ TPV is the first FDA-approved transcatheter valve system specifically designed to treat severe pulmonary regurgitation in patients with a native or surgically-repaired right ventricular outflow tract (RVOT) — offering your patients a minimally invasive treatment option.DOWNLOAD PRODUCT BROCHURE
The Harmony valve and frame are integrated to provide a one-step delivery process, facilitating predictable device deployment in the intended position.1
The Harmony Transcatheter Pulmonary Valve (TPV) System is indicated for use in the management of pediatric and adult patients with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography and/or pulmonary regurgitant fraction ≥ 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement.
Fully-sheathed delivery system is highly trackable through the vasculature.2
Harmony TPV is constructed of a self-expanding nitinol frame made up of individual wire struts, designed to conform to the native RVOT anatomy.
Porcine pericardial leaflets provide excellent kinematics across the full range of pressures of the right heart.3
Physicians who implant the Harmony valve receive dedicated support and guidance from clinical congenital heart disease (CHD) experts at all stages of the therapy:
Medtronic data on file. Human Factors Engineering Summative and Usability Design Validation Test Report – D00177328. Bench testing may not be representative of clinical performance. Bench testing performed in simulated anatomical fixture.
Medtronic data on File. Harmony System Human Factors Engineering Master Report – D00244206. Bench testing may not be representative of clinical performance. Bench testing performed in simulated anatomical fixture.
Medtronic data on file. Design Verification Test Report for Harmony TPV 22 Hydrodynamic Performance – D00266155. Design Verification Test Report for Hydrodynamic Performance of Harmony Modified TPV 25 – D00064319. Bench testing may not be representative of clinical performance (n = 6). Bench testing performed in a nonanatomical test fixture.