Posts Tagged ‘warfarin’

FDA Approval: On-X aortic valves with less warfarin

U.S. FDA Grants Expanded Labeling Claim to On-X Life Technologies, Reducing Blood-Thinning Requirements for Heart Valve Patients Thousands With On-X Aortic Implant May Be Able to Reduce Medication Regimen AUSTIN, TX — April 2, 2015 — Thousands of Americans with On-X® Aortic Heart Valves may be able to reduce their regular blood-thinning medication regimen, thanks to…

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On-X Life Technologies reports CE mark approval

On-X Life Technologies reports CE mark approval to sell its mechanical aortic heart valve with an expanded labeling claim: a reduction in the required use of blood thinners “This approval allows European clinicians to maintain patients on a lower dose of anticoagulant, which has been shown in a multicenter clinical trial (PROACT: Prospective On-X Anticoagulation…

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Aortic Aneurysm Success Story

“When my cardiologist indicated it was time for me to surgically address my ascending aortic aneurysm and degrading aortic valve, I undertook some research into what would be my best choice. I did not want to face the prospect of another open heart procedure when in my 80s, as would probably be required if I…

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AATS Report: PROACT

Prospective Randomized On-X Heart Valve Clinical Trial Provides Evidence of Reduced Complications On-X aortic valve trial is the first to formally study patients maintained at levels of anticoagulation below those currently recommended by professional society guidelines, helping to lessen anticoagulation-related complications AUSTIN, TX – May 6, 2013 – On-X® Life Technologies, Inc. (On-X LTI) announced…

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On-X Heart Valve PROACT Trial Report

On-X Heart Valve PROACT Trial Preliminary Report Provides Evidence toward Maintaining Patients with Less Warfarin Preliminary Results of FDA-Approved PROACT Trial show the On-X® Valve continues to demonstrate tolerance of low INR seen in worldwide studies AUSTIN, TX — April 06, 2011 — On-X® Life Technologies, Inc. announced today that preliminary results from a Food…

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On-X Heart Valve Shows Safety with Reduced Blood Thinners

On-X Heart Valve Shows Safety with Reduced Blood Thinners Early Data Reported From Large FDA IDE Clinical Trial is Encouraging New Orleans, LA — April 5, 2011 – Patients with a mechanical heart valve need lifelong treatment with blood-thinning drugs like warfarin − anticoagulants that prevent blood from clotting on the man-made material but also…

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Clinical Update Thirty-Six: Anticoagulant Drugs

The Ignored Benefits of Anticoagulant Drugs In an aging population, anticoagulant drugs provide benefits that are often ignored in favor of repeated valve operations.   Benefits of Warfarin Current heart valve selection criteria is heavily weighted toward tissue valve implants even when an increasing number of randomized or matched clinical studies show the risks of…

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