On-X Prosthetic Heart Valves: Important Milestones

1998

CE mark approval for Aortic and Mitral Valves with Standard sewing ring.

2000

CE mark approval for Mitral Valve with Conform-X sewing ring.

2001

US FDA approves On-X Aortic Valve with Standard sewing ring.

2002

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.

2006

US FDA approves IDE trial for lowered anticoagulation for the On-X Prosthetic Heart Valves (PROACT).

2007

CE mark approval for Aortic Valve with Standard and Conform-X sewing rings (with extended holder).

2009

Enrollment complete in the PROACT AVR high-risk aortic patient group.

2011

US FDA and CE mark approvals for On-X Ascending Aortic Prosthesis.

2012

CE mark approval for Aortic Valve with Anatomic sewing ring (with extended holder).

2013

US FDA approves On-X Aortic Heart Valves with Anatomic sewing cuff.

2014

CE mark approval for On-X Aortic Heart Valves with INR 1.5 - 2.0 after 3 months standard anticoagulation.

2015

US FDA approves On-X Aortic Heart Valves with INR 1.5–2.0 after 3 months standard anticoagulation.

2017

2017 AHA/ACC Guidelines include On-X Aortic Valve INR 1.5-2.0 in patients without risk of TE.2,*

* Reduce INR (International Normalized Ratio) after 3 months standard therapy.1

Table 2. AVR High-Risk Post-Randomization Event Comparison

Table 2. AVR High-Risk Post-Randomization Event Comparison

References

  1. On-X Prosthetic Heart Valve Instructions for Use.
  2. 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;••:•••–•••. DOI: 10.1161/CIR.0000000000000503.

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