Posts Tagged ‘on-x heart valve’
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…
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 MoreClinical Update Forty-One: On-X Heart Valve
The On-X Heart Valve at 12 years Long term follow-up of the On-X valve confirms its early performance of clinical excellence.1,2 European data establishes the On-X valve as market leader A three center retrospective study of 691 patients from 1998 through 2009 inclusivley produced low complication rates.1 John Chambers of Guy’s and St. Thomas…
Read MoreThe 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…
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 MoreHighlighting 15 Years of Implant Excellence
At the EACTS meeting in Lisbon, Portugal Two ten-year clinical research reports present evidence of continuing superior performance of the On-X® Prosthetic Heart Valve in diverse European and South African patient groups AUSTIN, TX — July 26, 2011 — On-X® Life Technologies, Inc. (On-X LTI) announced today that it is highlighting two clinical studies completed…
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 MoreClinical 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…
Read MoreOn-X Heart Valve Superior Performance
Large Canadian Heart Valve Study Provides Evidence of On-X® Heart Valve Superior Performance AUSTIN, TX — December 13, 2010 — On-X® Life Technologies, Inc. (On-X LTI), today announced the publication of results of a large, prospective multi-center Canadian trial with the On-X Prosthetic Heart Valve in the November issue of The Journal of Thoracic and…
Read MoreLow Postoperative Complications with On-X Valve
Clinical Study Reinforces Low Postoperative Complications with On-X Valve AUSTIN, TX — June 25, 2003 — Medical Carbon Research Institute, L.L.C. (“MCRI”), manufacturer of the On-X(R) Prosthetic Heart Valve, announced the presentation of clinical study results comparing rates of late complications (thrombosis, major bleeding and major thromboembolism) for the On-X valve and competing valves within…
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