HARMONY™ Transcatheter Pulmonary Valve

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

Overview

ONE. DONE. ONE-STEP DELIVERY

The Harmony valve and frame are integrated to provide a one-step delivery process, facilitating predictable device deployment in the intended position.1

INDICATIONS

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

TRANSCATHETER VALVE DESIGNED SPECIFICALLY FOR THE NATIVE RVOT

FULLY SHEATHED DELIVERY SYSTEM

Fully-sheathed delivery system is highly trackable through the vasculature.2

Harmony transcatheter pulmonary valve delivery system

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. 

The Harmony transcatheter pulmonary valve is encased in a self-expanding nitinol frame.

PERICARDIAL LEAFLETS

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

Harmony transcatheter pulmonary valve features porcine pericardial leaflets

SUPPORT FROM DEDICATED CLINICAL CHD EXPERTS

Female clinician looks at a laptop while holding a pair of glasses.

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 pre-, intra-, and post-operative support.
  • Post-implant: We are committed to data transparency, long-term data reporting, and enduring patient education.

DEVICE OVERVIEW

HARMONY TPV 22

Image showing dimensions of the Harmony 22 mm transcatheter pulmonary valve

HARMONY TPV 25

Image showing dimensions of the Harmony 25 mm transcatheter pulmonary valve

features

  • 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 DELIVERY CATHETER SYSTEM

Harmony delivery catheter system

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

ADDITIONAL RESOURCES

CHD communications

Get the latest updates from the congenital heart disease team at Medtronic.

SIGN UP FOR EMAILS

PRODUCT MANUALS

Access product manuals from the Medtronic Manual Library by searching for the product name or model number.

VISIT LIBRARY

EDUCATION AND 
RESOURCES

Find additional feature information, educational resources, and tools.

GO TO MEDTRONIC ACADEMY

GET SUPPORT

Reach out to LifeLine Cardiovascular Tech Support with questions.

877-526-7890
rs.structuralheart@medtronic.com

1

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.

2

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.

3

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.