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On-X® Aortic Heart Valve

Aortic Heart Valve

A Valve for Life.

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 >60% reduction in bleeding and no increase in thromboembolism (TE).1-2
  • Unique material and design provide optimal mean gradients compared with other bileaflet and bioprosthetic aortic valves at ≥1 year. 1,3-7

Product Overview

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1. 90° Leaflets

Promote laminar flow1

artivion-on-x-heart-valves

On-X Heart Valves

90° Opening
artivion-all-other-bileafelt-valves

All Other Bileaflet Valves

< 90° Opening

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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Cylindrical end

CYLINDRICAL END

Used to find the correct fit for aortic valve sizes 19-25mm.

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REPLICA END

Used after sizing to assure fit of the valve without obstruction of the coronary arteries for aortic valve sizes 19-25mm.

Conical ends

CONICAL ENDS

Used to find correct fit and assure intra-annular positioning for aortic valve sizes 27/29mm and 31/33mm.

Clinical Evidence

ON-X AORTIC HEART VALVE: 50% CLOSER TO A NORMAL INR1

Patients with an INR of 1.5–2.0 had a >60% reduction in bleeding events and no increase in TE compared to patients with an INR of 2.0–3.0.* All other bileaflet aortic valve anticoagulation should be managed at an INR of 2.0–3.0.2

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OPTIMAL HEMODYNAMICS

The On-X Aortic Valve provides optimal mean gradients compared with other bileaflet and bioprosthetic aortic valves at ≥1 year. 3-10,¥

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SURVIVAL AFTER VALVE REPLACEMENT: BIOLOGIC VS. MECHANICAL

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VALVE DURABILITY: REOPERATION VS. VALVE PERFORMANCE

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Featured Videos

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On-X Aortic Heart Valve Animation

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On-X Aortic Heart Valve Animation

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Additional Resources

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ORDERING INFORMATION

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MRI INFORMATION

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PATIENT INFORMATION SITE

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Product Highlights

  1. On-X Prosthetic Heart Valve Instructions for Use.
  2. Puskas JD, et al. J Am Coll Cardiol 2018;71:2717-26.
  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 Design Features

  1. On-X Prosthetic Heart Valve Instructions for Use.
  2. LaGrange L et al., Compatibility of carbon and blood. Hegyeli RJ, Editor, Proceedings, Artificial Heart Program Conference, Washington, DC, June 9-13, 1969, 47-58.

 

Clinical Evidence

  1. Nishimura et al., 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. 2017;135:e1159–e1195.
  2. Normal INR is considered 1. WHO Expert Committee on Biological Standardization, 33rd Report, World Health Organization, 1983.
  3. http://apps.who.int/iris/bitstream/10665/39217/1/WHO_TRS_687.pdf, downloaded on 06/29/2016.5. Data on file. 6. Levine M et al., Monitoring of international normalized ratios: comparison of community nurses with family physicians. Can Fam Physician 2012;58:e465-71.
  4. On-X Prosthetic Heart Valve Instructions for Use.
  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.
  10. ** Medtronic Open Pivot AP and AP360 (formerly ATS): 16 = 19, 18 = 21, 20 = 23, 22 = 25, 24 = 27, 26 = 29.
  11. ¥ Postoperative data. Note: Mean gradients for On-X Aortic Valve 27 and 29 were combined.