Harmony™ TPV system
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.
0%
vascular injury
requiring intervention*
Made for dynamic
RVOT anatomies
98%
freedom from major
stent fracture (TPV22)†
Made to conform to
the native RVOT
97%
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.
Made for patients like Hunter.
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.
Made for advancing TPV therapy.
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.
Made for the native RVOT.
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.
Designed specially for the native RVOT in three ways:
Fully sheathed delivery system
Fully sheathed delivery system is highly trackable through the vasculature.1
Self-expanding nitinol frame
Harmony TPV is constructed of a self-expanding nitinol frame made up of individual wire struts, designed to conform to the native RVOT anatomy.
Pericardial leaflets
Porcine pericardial leaflets provide excellent kinematics across the full range of pressures of the right heart.2,3
Valve features
- The valve and frame are integrated to provide a one-step delivery process, facilitating predictable device deployment in the intended position4
- Porcine pericardial tissue valve
- Self-expanding nitinol frame
- Polyester cloth covering
- Multiple valve sizes with different inflow diameters, outflow diameters, and lengths to fit a range of patient anatomies
Harmony TPV 22
Harmony TPV 25
Delivery catheter features
- Coil loading system facilitates simple loading of the valve
- Loading funnel to compress valve prior to sheathing
- Retractable sheath
- Ergonomic handle facilitates unsheathing and release of valve for final deployment
Harmony delivery catheter system
Made for performance, backed by support.
Physicians who implant the Harmony valve receive dedicated support and guidance from clinical congenital heart disease (CHD) experts at all stages of the therapy.
Physician training
The congenital medical education team provides multistep learning opportunities that build confidence and competency.
Implant
Dedicated clinical CHD experts provide pre-, intra-, and post-operative support.
Patient selection and screening
A proprietary fit analysis report assists with patient selection, device selection, and device placement.
Post-implant
We are committed to data transparency, long-term data reporting, and enduring patient education.
References
1
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.
2
Medtronic data on file. Design Verification Test Report for Harmony TPV 22 Hydrodynamic Performance — D00266155.
3
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.
4
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.