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.
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Overview
Harmony in every beat
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 congenital heart disease 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 pulmonary valve replacement as judged by the medical team.
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
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.3
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 sizing: A 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
HARMONY TPV 25
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
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
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 ACADEMYGET 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.
DISCLAIMER
The material on this website should not be considered the exclusive source of information, it does not replace or supersede information contained in the device manual(s). Please note that the intended use of a product may vary depending on geographical approvals.
See the device manual(s) for detailed information regarding the intended use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.
For a MRI compatible device(s), consult the MRI information in the device manual(s) before performing a MRI. If a device is eligible for eIFU usage, instructions for use can be found at Medtronic’s website manuals.medtronic.com.
Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.
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