Posts Tagged ‘proact’
On-X LTI Launches Innovative Heart Valve Products
European Meeting in Barcelona The On-X aortic valve with an anatomic shaped sewing ring and ePTFE suture for repair of mitral valve chordae presented at EACTS AUSTIN, TX – October 29, 2012 – On-X® Life Technologies, Inc. (On-X LTI) announced today that it is launching two new heart valve products, the On-X® Aortic Prosthetic Valve…
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 MoreOn-X Life Technologies Releases Expected Timelines
For Reduced Anticoagulation Study Results at AATS Results for PROACT Trial provide sufficient data to permit submission of modified “Instructions for Use” to the FDA for the On-X Heart Valve for high-risk patients, as well as interim results for low-risk (aspirin and clopidogrel) patients AUSTIN, TX – April 30, 2012 – On-X® Life Technologies, Inc.…
Read MoreOn-X Life Technologies to Highlight
Reduced Anticoagulation Study Results, Long-Term and Patient Survival Data with the On-X heart valve at STS Meeting Interim results for PROACT Trial, two ten-year clinical research reports and several clinical reports indicating longer survival for mechanical valve patients available to surgeons at The Society of Thoracic Surgeons Meeting AUSTIN, TX – January 24, 2012 –…
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 MoreOn-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…
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 LTI Completes Enrollment
On-X Life Technologies Completes Enrollment in High-Risk Patient Group Low Anticoagulation Trial Data from the PROACT Trial may provide evidence that the On-X valve may be appropriately maintained at lower levels of anticoagulation AUSTIN, TX — October 20, 2009 — On-X® Life Technologies, Inc. (On-X LTI), manufacturers of the On-X® Prosthetic Heart Valve and On-X®…
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…
Read More