Transcatheter valves
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.
Description
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
Watch the Harmony™ TPV procedure animation and observe a less-invasive approach to restore pulmonary valve function. (04:35)
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
Fully-sheathed delivery system
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.
Pericardial leaflets
Porcine pericardial leaflets provide excellent kinematics across the full range of pressures of the right heart.2,3
Valve features
Harmony™ TPV 22
Harmony™ TPV 25
- 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™ 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.
Ordering information
|
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 |
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References
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.