Made for this
Treating congenital heart disease patients takes focus. When you are in the moment, you need to make sure you have the right valve. The Harmony transcatheter pulmonary valve (TPV) system is made for this moment.
The only one.
Harmony TPV is the only transcatheter pulmonary valve designed specifically for the RVOT with demonstrated consistent two-year outcomes.
Made for dynamic
freedom from major
stent fracture (TPV22)†
Made to conform to
the native RVOT
none/trace or mild
PR at two years†
Made to reliably improve pulmonary regurgitation (PR)
* N = 89.
† N = 86.
Data is provided from the Harmony TPV Clinical Study through two years.
Harmony TPV risks may include, but are not limited to, non-sustained ventricular tachycardia, premature ventricular contraction, minor paravalvular leak, stenosis, and migration of the TPV.
Hunter, born with tetralogy of Fallot, is living his life to the fullest thanks to his transcatheter pulmonary valve procedure in 2021.
Learn why Harmony TPV is made for Hunter.
The Harmony TPV was intentionally designed for the native RVOT. It conforms to the anatomy and has an integrated valve and frame to allow a one-step delivery.
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.
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.
Fully sheathed delivery system is highly trackable through the vasculature.1
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.2,3
Harmony TPV 22
Harmony TPV 25
Harmony delivery catheter system
Physicians who implant the Harmony valve receive dedicated support and guidance from clinical congenital heart disease (CHD) experts at all stages of the therapy.
The congenital medical education team provides multistep learning opportunities that build confidence and competency.
Dedicated clinical CHD experts provide pre-, intra-, and post-operative support.
A proprietary fit analysis report assists with patient selection, device selection, and device placement.
We are committed to data transparency, long-term data reporting, and enduring patient education.
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 non-anatomical test fixture.
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.