Posts Tagged ‘proact’

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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OnXLTI prepares to sell On-X Plus 1.5 Aortic Heart Valve

On-X LTI prepares European sales force to sell On-X® Plus 1.5™ Aortic Heart Valve “While the On-X® Plus 1.5™ Aortic Heart Valve represents a new paradigm by which clinicians can manage their patients on a reduced dose of warfarin, we are proud to note that On-X has been successfully selling mechanical valves in Europe since…

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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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On-X Heart Valve Study Results

Presented at the Society for Heart Valve Disease 7th Biennial Congress Two PROACT Abstracts Present Data Showing Patients on Low Anticoagulation Therapy Do Well with the On-X® Prosthetic Heart Valve AUSTIN, TX — June 25, 2013 — On-X® Life Technologies, Inc. (On-X LTI) announced today that two new PROACT abstracts further demonstrating the safety of…

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ISPOR Meeting Presentation

Economic Model of the Life-time Cost Impact of Heart Valve Prosthetic Choice Life-time costs savings of choosing an On-X® Prosthetic Heart Valve with no risk of re-operation compared to a stented tissue valve replaced with a transcatheter valve is estimated at $376,000 AUSTIN, TX — May 21, 2013 — On-X® Life Technologies, Inc. (On-X LTI)…

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Enrollment Completed

Low-Risk Aortic and Mitral Patient Groups for On-X Prosthetic Heart Valve Anticoagulation Clinical Study Low-risk aortic valve patients are maintained with aspirin and clopidogrel only AUSTIN, TX – May 7, 2013 – On-X® Life Technologies, Inc. (On-X LTI) announced today that enrollment for the Low-Risk Aortic Valve and Mitral Valve Patient Groups has been completed.…

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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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Predicting Long-Term Costs

Heart Valve Replacement Study to be Presented at American College of Cardiology Meeting A comparative long-term cost analysis between the On-X® Prosthetic Heart Valve and stented tissue valves shows a potential life-time savings of nearly $60,000 per patient and $1.2 billion for total U.S. healthcare AUSTIN, TX – March 8, 2013 – On-X® Life Technologies,…

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On-X LTI Receives FDA Approval

On-X Heart Valve with Anatomic Shaped Sewing Ring The On-X Aortic Heart Valve with an anatomic shaped sewing ring matches the shape of the native aortic annulus and helps prevent flattening and distortion AUSTIN, TX – February 26, 2013 – On-X® Life Technologies, Inc. (On-X LTI) announced today that it has received approval from the…

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