Posts Tagged ‘clinical research’

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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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 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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The On-X® Heart Valve Compares Favorably to Tissue Valves

Results from a study comparing the On-X mechanical heart valve to tissue valves Matched Patient Groups in Reduced Anticoagulation Trial Provide Evidence of Improved Mortality Rate for Patients AUSTIN, TX – May 23, 2012 – On-X® Life Technologies, Inc. (On-X LTI) announced today that results from a study comparing the On-X mechanical heart valve to…

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Enrollment Objective Achieved

FDA-approved PROACT (Prospective Randomized On-X Anticoagulation Trial) expects to complete enrollment for all patient groups in 2011 AUSTIN, TX — July 26, 2011 — On-X® Life Technologies, Inc. (On-X LTI) announced today that the enrollment objective for the Low-Risk Aortic Valve Patient Group has been achieved. The Prospective Randomized On-X Valve Anticoagulation Trial (PROACT) was…

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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-Four: On-X Heart Valve Outperform

On-X Heart Valves outperform tissue valves in a matched study On-X® Prosthetic Heart Valve patients in a prospective study matched to patients implanted with tissue valves showed a definite advantage in mortality.1   The On-X® Prosthetic Heart Valve provides lower mortality Study results reported at the recent Society of Thoracic Surgeons (STS) meeting in San…

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