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Alert Indications, Safety, and Warnings

Harmony™  transcatheter pulmonary valve

The Harmony™ transcatheter pulmonary valve is designed to treat severe pulmonary regurgitation in patients with a native or surgically-repaired RVOT.

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View the Harmony™ transcatheter pulmonary valve, shown partially deployed on the delivery system.
Alert Indications, Safety, and Warnings

Overview

Harmony™  transcatheter pulmonary valve (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). This valve offers your patients a minimally invasive treatment option.

Features


Valve and system overview 

The Harmony™ transcatheter pulmonary valve is specifically designed for the native RVOT.

Fully-sheathed delivery system

This delivery system is highly trackable through the vasculature.1

Product image of the Harmony™ TPV 25 capsule delivery system
Self-expanded nitinol frame

The Harmony™ TPV is constructed of a self-expanding nitinol frame made up of individual wire struts, designed to conform to the native RVOT anatomy.

Product image of a Harmony™ TPV 25 nitinol frame
Pericardial leaflets

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

Product image of Harmony™ TPV leaflets shown via X-ray imaging

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

Product image of a Harmony™ 22 transcatheter pulmonary valve on a transparent background within a blue circle

Harmony™ TPV 25

Product image of a Harmony™ 25 transcatheter pulmonary valve on a transparent background centered within an outline of a blue circle

Harmony™ delivery catheter system

Product image of the Harmony™ TPV delivery catheter system
  • 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

Support from dedicated clinical CHD experts

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 multi-step learning opportunities that build confidence and competency.
  • Patient selection and screening: a proprietary fit analysis report assists with patient selection, device selection, and device placement.
  • Implant: dedicated clinical CHD experts provide properative, intraoperative, and postoperative support.
  • Post-implant: we are committed to data transparency, long-term data reporting, and enduring patient education.
Female clinician looks at a laptop while holding a pair of glasses.

Ordering information

Item number Description

HARMONY-22

Harmony™ transcatheter pulmonary valve, 22 mm

HARMONY-25

Harmony™ transcatheter pulmonary valve, 25 mm

HARMONY-DCS

Harmony™ transcatheter pulmonary valve delivery catheter system — use with the Harmony-22 and Harmony-25

Related products

Melody transcatheter pulmonary valve (TPV) right-facing
 
Melody™ transcatheter pulmonary valve
Contegra
Contegra™ pulmonary valved conduit

  

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1

Medtronic data on file. Based on internal report D00244206, Harmony system human factors engineering master. Bench testing may not be representative of clinical performance, performed in simulated anatomical fixture.

2

Medtronic data on file. Based on internal design verification test report D00266155, Harmony TPV 22 hydrodynamic performance. Bench testing may not be representative of clinical performance (n = 6). Bench testing performed in a nonanatomical test fixture.

3

Medtronic data on file. Based on internal design verification test report D00064319, hydrodynamic performance of Harmony modified TPV 25. Bench testing may not be representative of clinical performance (n = 6). Bench testing performed in a nonanatomical test fixture.

4

Medtronic data on file. Based on internal 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.