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On-X®

AORTIC HEART VALVE

A Valve for Life.

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Product Highlights

  • The only aortic mechanical valve with FDA, Health Canada, and CE Mark approval for Low INR of 1.5 – 2.0.1*
  • Clinically proven to be safer with less anticoagulation resulting in 87% reduction in bleeding, with no increase in thromboembolism and no valve thrombosis.2*
  • Unique material and design provide optimal hemodynamics compared with other mechanical and bioprosthetic aortic valves at ≥1 year. 1,3-7

 

*Reduce INR after 3 months of standard therapy.1

Product Overview

Design Features Accessories
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1. 90° Leaflet Opening

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On-X Heart Valves

90° leaflet opening organizes flow1, reducing turbulence and thrombogenicity.3
artivion-all-other-bileafelt-valves

All Other Bileaflet Valves

< 90º leaflet opening can lead to turbulent flow.3

2. Pure Pyrolytic Carbon

Designed to reduce thrombogenicity1-2

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Pure Pyrolytic Carbon2

Other Silicon Alloyed Pyrolutic carbon@2x 1

Silicon-Alloyed Pyrolytic Carbon2

3. Complete Annulus Support

Flared inlet organizes flow & prevents pannus1

Complete Annulus Support

Complete Annulus Support

Incomplete Annulus Support (2)

Incomplete Annulus Support

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On-X Aortic Heart Valve Sizer
On-X Call Out

CYLINDRICAL END

For aortic valve sizes 19-25mm, the cylindrical end is used to find the correct fit.

On-X-Call-Out-Replica-End

REPLICA END

For aortic valve sizes 19-25mm, the replica end is used after sizing to ensure the fit of the valve without obstructing the coronary arteries.

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Conical End Sizer

For aortic valve sizes 27/29mm and 31/33mm, the conical end sizer is used to find the correct fit and assure intra-annular positioning.

The only artificial aortic valve to provide flow nearly the same as healthy human aortic valves is the On-X.

Dr. Marc W. Gerdisch, United States

The bleeding risk associated with mechanical valves is almost nullified by a lower anticoagulation option [with the On-X Aortic Heart Valve], and the hemodynamics do not deteriorate over time as do bioprosthetic valves that place the patient in a watchful waiting phase toward the valve end of life.

Dr. Mohanakrishnan Sathyamoorthy, United States

Clinical Evidence

87% Lower Bleeding Risk with 50% Lower INR1

The On-X Aortic Heart Valve Post Approval Study (PAS) 5-year interim data determined that in a real-world setting, the On-X Aortic Valve managed at a low INR of 1.5-2.0 demonstrates an 87% reduction in major bleeding (MB) with no increase in thromboembolism (TE) and no valve thrombosis (VT) when compared to standard INR of 2.0-3.0.*1 All other mechanical aortic valve anticoagulation should be managed at an INR of 2.0-3.0.2

 

*Reduce INR after 3 months post-operative standard therapy.4

 

Open Access Publication – View here:
Low-dose warfarin with a novel mechanical aortic valve: Interim registry results at 5-year follow-up

 

 

 

PAS-5-Year-Outcomes

OPTIMAL HEMODYNAMICS

The On-X Aortic Valve provides optimal mean gradients compared with other bileaflet and bioprosthetic aortic valves at ≥1 year.4-9

Mean-Gradients

Product Animation

The animation below demonstrates how the unique material and design features of the On-X Aortic Heart Valve promote laminar blood flow and reduce thrombogenicity.

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

DOWNLOAD

MRI INFORMATION

Download PDF

PATIENT INFORMATION SITE

VISIT PATIENT SITE

ON-X POST APPROVAL STUDY CLINICAL SUMMARY

DOWNLOAD PDF

Product Highlights

  1. On-X Prosthetic Heart Valve Instructions for Use (01012277E).
  2. Gerdisch MW. et al. (2024) Low-Dose Warfarin with a Novel Mechanical Aortic Valve: Interim Registry Results at 5-Year Follow-Up. J Thorac Cardiovasc Surg. doi: https://doi.org/10.1016/j.jtcvs.2024.04.017.
  3. St. Jude Medical Physician’s Manual Mechanical Heart Valve.
  4. CarboMedics Prosthetic Heart Valve Instructions for Use.
  5. Medtronic Open Pivot Heart Valve Instructions for Use.
  6. Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use.
  7. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use.

 

Product Overview

  1. On-X Prosthetic Heart Valve Instructions for Use (01012277E).
  2. LaGrange L, et. al. (1969, June 9-13). Compatibility of carbon and blood. Artificial Heart Program Conference, Washington, DC.
  3. 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. 

 

Clinical Evidence

  1. Gerdisch MW. et al. (2024) Low-Dose Warfarin with a Novel Mechanical Aortic Valve: Interim Registry Results at 5-Year Follow-Up. J Thorac Cardiovasc Surg. doi: https://doi.org/10.1016/j.jtcvs.2024.04.017.
  2. Nishimura RA, et. al. (2017) 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation, 135, e1159–95.
  3. Artivion data on file, weighted average of control groups from FDA Premarket Approval P000037 S030 and IDE trial G050208.
  4. On-X Prosthetic Heart Valve Instructions for Use (01012277E).
  5. St. Jude Medical Physician’s Manual Mechanical Heart Valve.
  6. CarboMedics Prosthetic Heart Valve Instructions for Use.
  7. Medtronic Open Pivot Heart Valve Instructions for Use.
  8. Edwards Life Sciences Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use.
  9. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use.

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. MWENG0038.000 (2024-08)

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