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On-X®

MITRAL HEART VALVE

A Mitral Valve For Life.

Product Highlights

  • Engineered for Exceptional Clinical Performance.1

  • 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

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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

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On-X Valves

90° opening organizes flow, reducing turbulence and thrombogenicity2
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Other Mechanical Valves

< 90º leaflet opening can lead to turbulent flow 7

3. PURE ON-X PYROLYTIC CARBON

Designed to reduce thrombogenicity.

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Pure Pyrolytic Carbon8,9

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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
On-X Mitral Design Feateres

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

 

Click here to download the publication. 

Additional-Charts

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 althat show in patients up to 70 years of age, mechanical mitral valves have a survival benefit at 15 years over tissue valves.

 

Click here to download
Clinical Summary Survival Data

 

 

MV-charts-1

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

 

Click here to download
Clinical Summary Hemodynamic Data

MV-charts-2

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.

 

Click here to download
Clinical Summary Quality of Life Data

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Product Animation

Additional Resources

Explore additional resources for On-X below. For further information or to contact a sales associate in your area, contact us.

Ordering Information

MRI Information

Patient Information Site

Product Highlights

  1. 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.
  2. On-X Heart Valve Instructions for Use (010122 77)
  3. 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. 
  4. 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.
  5. Gao BZ et al. (1997)  Hydrodynamics of a long-body bileaflet mechanical heart valve. ASAIO J. 43(5):M396-401.
  6. 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.
  7. 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. 
  8. LaGrange L et al. Compatibility of carbon and blood. Poster presented at: Artificial Heart Program Conference;  June 9-13, 1969; Washington, DC.
  9. More R et al. (1996)  Surface chemistry and surface roughness of clinical pyrocarbons.  Cells and Materials.,6 (4): 273-79.
  10. 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

  1. Goldstone AB. et al. (2017) Mechanical or biologic prostheses for aortic-valve and mitral-valve replacement. N Engl J Med;377:1847–57.
  2. 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.
  3. 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.
  4. 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)

On-X Life Technologies, 1300 E Anderson Ln, Austin, TX 78752, US