Posts Tagged ‘anticoagulation’
Interim Results From the PROACT Randomized FDA IDE Trial
Reduced Anticoagulation After Mechanical Aortic Valve Replacement Narrated slide presentation from The American Association for Thoracic Surgery Annual Meeting 2013, Minneapolis, Minnesota, USA, on May 6, 2013
Read MoreISPOR 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)…
Read MoreEnrollment 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.…
Read MoreAATS 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…
Read MoreOn-X Life Technologies Submits for FDA/CE Approval
Reduced Anticoagulation Indication for On-X Aortic Heart Valve If approval is received, the On-X valve will become the first aortic valve that allows patients to be maintained at levels of anticoagulation below currently recommended professional society guidelines, helping to lessen anticoagulation – related complications AUSTIN, TX – October 22, 2012 – On-X® Life Technologies, Inc.…
Read MoreEnrollment 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…
Read MoreClinical 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…
Read MoreClinical Update Thirty-Five: Lowered Anticoagulation
Lowered Anticoagulation Trial Preliminary Results The On-X® Prosthetic Heart Valve continues to demonstrate tolerance of low INR that has been seen in worldwide studies. A unique study of On-X heart valves The Prospective Randomized On-X Valve Anticoagulation Trial (PROACT) was initiated in 2006 and is currently ongoing in 36 centers throughout the United States…
Read MoreOn-X Valve Reduced Anticoagulation Clinical Trial
FDA approved an investigational device exemption clinical trial of the On-X Prosthetic Heart Valve Successful completion of the clinical study could result in the On-X valve becoming the only mechanical heart valve approved for low-dose anticoagulation therapy. AUSTIN, TX — January 13, 2006 — The U.S. Food and Drug Administration (FDA) has approved an investigational…
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