On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study
Prospective Randomized On-X Anticoagulation Clinical Trial Mitral Arm
On-X bi-leaflet mechanical heart valve in the mitral position.
On-X Heart Valve Clinical Milestones
US FDA approves On-X Aortic Valve with Standard sewing ring.
US FDA approves On-X Mitral Valve with Standard and Conform-X sewing rings. CE mark approval for Aortic Valve with Conform-X sewing ring.
US FDA approves IDE trial for lowered anticoagulation for the On-X Prosthetic Heart Valves (PROACT).
Enrollment complete in the PROACT Aortic Valve Replacement high-risk aortic patient group.
US FDA approves On-X Aortic Heart Valves with INR 1.5–2.0 after 3 months standard anticoagulation.
2017 AHA/ACC Guidelines include On-X Aortic Valve INR 1.5-2.0 in patients without risk of TE.2,*
*After 3 months standard therapy.
Enrollment complete for Mitral Arm of PROACT.
Clinical Trial References
- Otto CM, et al. Circulation. 2021;143: doi: 10.1161/CIR.0000000000000923.
- Granger C. et al. N Engl J Med 2011; 365:981-992 DOI: 10.1056/NEJMoa1107039.
Important Safety Information
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