Why On-X

Why ON-X

On-X Heart Valves represent the pinnacle of mechanical heart valve technology resulting in a unique heart valve with exceptional design and material features that are changing the way patients view heart valve replacement options.

Why Use Any Other Mechanical Valve When…

No Other Mechanical Valve Has 90° Leaflets1

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No Other Mechanical Valve Has 90° Leaflets


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Why On-X Valve

No Other Mechanical Valve Has Flared Inlets1,2

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No Other Mechanical Valve Has Flared Inlets


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No Other Mechanical Valve Has On-X Carbon3,4

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No Other Mechanical Valve Has On-X Carbon


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A Valve For Life

Patients younger than 70 years of age undergoing heart surgery with a mechanical heart valve live longer as compared to a tissue valve.5-7 Living longer is known as a “survival benefit” and this can be achieved with the On-X Aortic and Mitral Heart Valves made of pure pyrolytic carbon designed TO LAST A LIFETIME.5-9

On-X Aortic Valve 

Why On-X Aortic Valve
Clinically Proven To Be Safer

The On-X Aortic Heart Valve is the only mechanical heart valve FDA approved and clinically proven to be safer10 with less anticoagulation and INR level of 1.5 – 2.0.1,11*

87% Lower Bleeding Risk

With 87% reduced bleeding risk10,  the On-X Aortic Valve is clinically proven to be safe at lower warfarin dosing and is the only aortic valve supported by the AHA/ACC guidelines11 to be safely managed 50% closer to a normal INR level of 1.5 – 2.0 (vs. 2.0 – 3.0 for other mechanical valves)12

On-X Mitral Valve 

Why On-X Mitral Valve
The Most Studied Mechanical Mitral Valve

The Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) Mitral Trial1 is one of the largest studies ever conducted with mechanical mitral valves.  PROACT Mitral represents the most contemporary clinical data for any mechanical mitral valve; due to its size and scope, a similar study is likely to never be repeated.16

On-X Aortic Valve 

Clinically Proven To Be Safer

The On-X Aortic Heart Valve is the only mechanical heart valve FDA approved and clinically proven to be safer10 with less anticoagulation and INR level of 1.5 – 2.0.1,11*

60% Less Reported Bleeding

With >60% less reported bleeding,10 On-X Aortic Heart Valve is clinically proven, and the only aortic valve supported by the AHA/ACC guidelines11 to be safely managed 50% closer to a normal INR level of 1.5 – 2.0 (vs. 2.0 – 3.0 for other mechanical valves)12

The Only Mechanical Aortic Heart Valve Currently Enrolling PROACT Xa
On-X Aortic Heart Valve is the only mechanical aortic heart valve currently enrolling into PROACT Xa13 clinical study to determine if participants with On-X Heart Valve can be safely maintained on Apixaban. Apixaban does not require INR level measurement.14

Hear from An On-X Aortic Heart Valve Patient

 

On-X Mitral Valve 

The On-X Mitral Heart Valve is The Only Mitral Mechanical Valve Participating in An Ongoing Clinical Study
The On-X Mitral Heart Valve is the only mitral mechanical heart valve participating in an ongoing clinical study to determine if patients with the On-X Mitral Heart Valve can be safely and effectively maintained on less aggressive anticoagulation therapy than is currently being recommended by ACC/AHA Guidelines.11,15
The PROACT Mitral Clinical Study
The PROACT Mitral Clinical Study is to determine if it is safe for On-X Mitral Heart Valve patients to maintain a long term INR level between 2.0 – 2.5 combined with an Aspirin dosage of 81 mg/day after 90 days from implant (the first 90 days have a target INR level of 2.5 – 3.5).15 All other mechanical mitral valves must be maintained at an INR level of 2.5 – 3.5.11

Hear From An On-X Mitral Heart Valve Patient

 

Hear from An
On-X Aortic Heart Valve Patient

 

Hear From An
On-X Mitral Heart Valve Patient

 

Click Here to View References
Q

Why On-X References

  1. On-X Heart Valve Instructions for Use. https://www.onxlti.com/ifu/.
  2. Gao B. Z., et al. ASAIO Journal 1997;43;5: 396-401.
  3. Rodriguez-Gabella T, et al. J Am Coll Cardiol 2017;70(8):1013-28.
  4. Ely J, et al. J Heart Valve Dis 1998;7(6): 626-632.
  5. Glaser N, et al. Euro Heart J. 2016;37:2658-67.
  6. Kytö V, et al. The Annals of Thoracic Surgery 2019. https://doi.org/10.1016/j.athoracsur.2019.10.027.
  7. Diaz R, et al. J Thorac Cardiovasc Surg 2019;158(3):706-14.
  8. Goldstone AB et al; New Engl J. Med;2017:377:1847-57.
  9. Data on file: Lifetime of On-X Valve Study.
  10. Gerdisch MW, et al. J Thorac Cardiovasc Surg (2024), doi: https://doi.org/10.1016/j.jtcvs.2024.04.017.
  11. Otto CM, et al. Circulation. 2021;143: doi: 10.1161/CIR.0000000000000923.
  12. MedlinePlus. Normal INR Levels. https://medlineplus.gov/ency/article/003652.htm.
  13. ClinicalTrials.gov PROACT Xa Study. https://www.clinicaltrials.gov/ct2/show/NCT04142658?term=PROACT+Xa&draw=2&rank=1
  14. Granger C, et al. N Engl J Med 2011; 365:981-992 DOI: 10.1056/NEJMoa1107039.
  15. ClinicalTrials.gov PROACT MITRAL. https://clinicaltrials.gov/ct2/show/NCT00291525?term=proact&spons=on-x&draw=2&rank=1.
  16. Chu M.W.A., et al. (2023). Low-Dose Vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial. Ann Thorac Surg., S0003-4975 (23)00005-X.
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Important Safety Information

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