Better
Blood
Balance.

FDA Approved:

On-X® Aortic Heart Valve patients should be managed at INR 1.5–2.0.*

65% fewer bleeds, no increase in TE only with On-X Aortic Heart Valves.1-2

*Reduce INR after 3 months standard therapy.

Better Blood Balance

Low Thrombogenicity by Design

The On-X Aortic Heart Valve is designed to minimize hemostasis and hemolysis, making it the only mechanical valve that is safer with less anticoagulation.

  • On-X Valve Features
  • Less Blood Damage

    The On-X valve is the only mechanical valve with average LDH levels in the normal range (below 250 U/L).3 Less hemolysis leads to less platelet activation and less clotting.

    Pure Pyrolytic Carbon

    The carbon surface of the On-X valve smoother than any other valve, greatly reducing thrombogenicity.

    90° Leaflets

    On-X valve leaflets open to 90° to minimize turbulence and allow a more natural spiral blood flow.

    Smooth Pivots

    Only On-X valve pivots are free of sharp corners and machining marks. This eliminates hemostasis by completely purging the pivots with every beat.

    Flared Inlet

    The flared inlet promotes laminar flow with reduced turbulent shear stress and less hemolysis.

PROACT Results

Prospective Randomized On-X Valve Anticoagulation Clinical Trial

Sweet Spot
  • 65% Fewer Bleeds
  • No Increase in TE
  • INR: 1.5–2.0
  • 63,000 INR Data Points
  • 33 US Centers
PROACT Data

FDA Approved Labeling

Adequate anticoagulant or anticoagulant/antiplatelet therapy should be administered. Selection of an anticoagulant or anticoagulant/antiplatelet regimen is based on the particular needs of the patient and the clinical situation.

Patients with an On-X valve in the aortic valve position should be maintained on long-term warfarin anticoagulation which should achieve an International Normalized Ratio (INR) of 2.0 – 3.0 for the first 3 months after valve replacement surgery, after which the INR should be reduced to 1.5 – 2.0. Patients with an On-X valve in the mitral valve position or in multiple valve positions should be maintained at an INR of 2.5 – 3.5 continuously after valve replacement surgery. The addition of a daily aspirin at a dose from 75 to 100 mg is also recommended for patients with an On-X valve in any valve position, unless there is a contraindication to the use of aspirin.

Studies show that stable control of INR provides better clinical results and that patients should be regularly monitored. The use of home monitoring to accomplish stable INR control is recommended.

Contact Us

Request more information about the On-X Aortic Heart Valves, request a representative visit, or ask us a specific question.

  • What sewing cuff options are there?
  • Is reduced anticoagulation available for mitral valve patients?

    The PROACT study includes On-X mitral valves, but that arm of the study is not yet complete. Reduced anticoagulation results for mitral valves are forthcoming.

  • What do I need to know about implant technique for the On-X valve?
  • Disclaimers and References

    On-X aortic and mitral valves are FDA approved.

    Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the Instructions for Use that accompany the valve for indications, contraindications, warnings, precautions and possible complications.

    1. Puskas J, Gerdisch M, Nichols D, et al. Reduced anticoagulation after mechanical aortic valve replacement: interim results from the Prospective Randomized On-X© Valve Anticoagulation Clinical Trial randomized Food and Drug Administration investigational device exemption trial. J Thorac Cardiovasc Surg. 2014;147(4):1202-1211.

    2. Yanagawa B, Levitsky S, Puskas JD, et al. Reduced anticoagulation as safe in high risk patients with the On-X mechanical aortic valve. Current Opinion in Cardiology 2015; 30:140-5.

    3. Birnbaum D., Laczkovics A, Heidt M, Oelert H, Laufer G, Greve H, Pomar JL, Mohr F, Haverich A, Regensburger D., Examination of hemolytic potential with the On-X® prosthetic heart valve. J Heart Valve Dis. 2000; 9(1):142-5.