On-X®
MITRAL HEART VALVE
A Mitral Valve For Life.
Product Highlights
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Engineered for Exceptional Clinical Performance.1
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Optimal Hemodynamics: mean gradients ≤ 4.4 mmHG across all valve sizes ≥ 25 mm1 reducing risk of PPM.2,3,4
- Optimal Length & Leaflet guards: designed to conceal pledgets, reduce risk of pannus and provide complete annular support when retaining subvalvular structure.2,5,6
Product Overview
1. OPTIMAL VALVE LENGTH
Optimal length designed to conceal pledgets, reduce the risk of pannus, and provide complete annular support while retaining sub-valvular structure. 2,5,6
2. 90° LEAFLET OPENING
On-X Valves
90° opening organizes flow, reducing turbulence and thrombogenicity2
Other Mechanical Valves
< 90º leaflet opening can lead to turbulent flow 7
3. PURE ON-X PYROLYTIC CARBON
Designed to reduce thrombogenicity.
Pure Pyrolytic Carbon8,9
Silicone-Alloyed Pyrolytic Carbon8,9
4. CONFORM-X CUFF
- Large, “conforming” Conform-X Cuff designed to provide ease of implant
- Facilitates mitral valve replacement in patients presenting with mitral annular calcification (MAC)10
- Designed to serve as a buffer reducing paravalvular leaks.10
The On-X Conform-X Cuff works very nicely if the annulus is heavily calcified and you need to have the sewing cuff to conform to the annulus. The Conform-X Cuff is quite broad and sits super annular on top covering the annulus.
Clinical Evidence
Mechanical Valves Demonstrate Survival Benefit 1
Study shows survival benefit for recipients of mitral valve mechanical prostheses at 15 years for patients up to 70 years1
On-X Mitral Heart Valve: Survival Data
The PROACT Mitral Study data2,3 showed On-X Mitral Valve replacement patients with standard-dose anticoagulation had excellent survival rates of:
- 99.5% at 1 year
- 94% at 3 years
- 91% at 5 years
Complementing other large-scale analysis such as Goldstone et al1 that show in patients up to 70 years of age, mechanical mitral valves have a survival benefit at 15 years over tissue valves.
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Clinical Summary Survival Data
On-X Mitral Heart Valve: Hemodynamic Data
On-X Mitral Heart Valve replacement patients had exceptional mean gradients below 5mmHg across all On-X Mitral Heart Valves sizes, sustained out to 5 years.4
On-X Mitral Heart Valve: Quality of Life Data
On-X Mitral Heart Valve Data4 Demonstrates Excellent and Sustained Quality of Life Improvement for Patients with On-X Mitral Heart Valve replacement.
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Clinical Summary Quality of Life Data
Additional Resources
Explore additional resources for On-X below. For further information or to contact a sales associate in your area, contact us.
Product Highlights
- Chu Michael W.A. , et al. (2023) Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial. Ann Thorac Surg., S0003-4975(23)00005-X. doi: 10.1016/j.athoracsur.2022.12.031.
- On-X Heart Valve Instructions for Use (010122 77)
- Magne J et al. (2007) Impact of prosthesis-patient mismatch on survival after mitral valve replacement. Circ. 20;115(11):1417-25. doi: 10.1161/ CIRCULATIONAHA.106.631549.
- Lam BK et al. (2007) The impact of patient–prosthesis mismatch on late outcomes after mitral valve replacement. J Thorac Cardiovasc Surg. 133(6):1464-73.
- Gao BZ et al. (1997) Hydrodynamics of a long-body bileaflet mechanical heart valve. ASAIO J. 43(5):M396-401.
- Tanaka H et al. (2006) Feasibility of preservation of subvalvular apparatus in mitral valve replacement with the On-X mechanical valve. J Thorac Cardiovasc Surg. 132(6):1470-1. doi: 10.1016/j.jtcvs.2006.08.030.
- Gerdisch M. et al. (2022) The role of mechanical valves in the aortic position in the era of bioprostheses and TAVR: Evidence-based appraisal and focus on the On-X valve. Prog Cardiovasc Dis. 72:31-40. doi: 10.1016/j.pcad.2022.06.001.
- LaGrange L et al. Compatibility of carbon and blood. Poster presented at: Artificial Heart Program Conference; June 9-13, 1969; Washington, DC.
- More R et al. (1996) Surface chemistry and surface roughness of clinical pyrocarbons. Cells and Materials.,6 (4): 273-79.
- Wippermann J. et al. (2005) Three years’ experience with the On-X Conform-X bileaflet prosthesis for ‘atrialized’ mitral valve replacement: a preliminary report. J Heart Valve Dis.; 14(5):637-643.
Clinical Evidence
- Goldstone AB. et al. (2017) Mechanical or biologic prostheses for aortic-valve and mitral-valve replacement. N Engl J Med;377:1847–57.
- Chu Michael W.A. , et al. (2023)Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial. Ann Thorac Surg., S0003-4975(23)00005-X. doi: 10.1016/j.athoracsur.2022.12.031.
- Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Controlled Trial. Presented at Society of Thoracic Surgeons Annual Meeting, January 2022. Chu Michael, Ruel Marc, et al.
- Data on file.
All products and indications are not available/approved in all markets. All trademarks are owned by Artivion, Inc. or its subsidiaries. On-X Life Technologies, Inc., Jotec GmbH, and Ascyrus Medical GmbH are wholly owned subsidiaries of Artivion, Inc. MWENG0026.000 (2024-06)
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On-X Life Technologies, 1300 E Anderson Ln, Austin, TX 78752, US |