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 TPV system is made for this moment.

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Harmony TPV shown in the hand of a person wearing white gloves
Alert Indications, Safety, and Warnings

Innovation

Made for advancing TPV therapy.

The Harmony TPV was intentionally designed specifically for the native RVOT. It conforms to the anatomy and has an integrated valve and frame to allow a one-step delivery. 

Indication

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.

Valve and system overview

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

Harmony TPV 25 capsule delivery system on a transparent background

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.

Harmony TPV 25 nitinol frame on a transparent background

Pericardial leaflets

Porcine pericardial leaflets provide excellent kinematics across the full range of pressures of the right heart.2,3

Harmony TPV leaflets on a transparent background

  

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 22 valve on a transparent background within a blue circle

Harmony TPV 25

Harmony TPV 25 valve on a transparent background within a blue circle

  

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

Harmony TPV delivery catheter system on white background

Clinical support

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.

Decorative element

Physician training

The congenital medical education team provides multistep learning opportunities that build confidence and competency.

Decorative element

Implant

Dedicated clinical CHD experts provide pre-, intra-, and post-operative support.

Decorative element

Patient selection and screening

A proprietary fit analysis report assists with patient selection, device selection, and device placement.

Decorative element

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 nonanatomical 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.