Page 8 – On-X Life Technologies, Inc.

Clinical 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…

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…

On-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.…

On-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 –…

Clinical Update Thirty-Nine: Tissue Valve Failure

Factors leading to premature tissue valve failure Accelerated failure of biological valve replacements due to diabetes, atherosclerosis, metabolic syndrome, hypercholesterolemia and patient-prosthesis mismatch puts patients at risk.1-5 Recently published studies describe a variety of conditions common in patients with heart valve disease that can cause early tissue valve failure. Diabetes is a 3X higher…

Clinical Update Thirty-Eight: Improved Mortality

Improved mortality for mechanical valve patients Several recent clinical trials provide evidence of superior durability, reoperation rates and mortality for mechanical valve recipients compared to biological valve recipients.1-9 Matched study results favor mechanical valves In an abstract presented earlier this year at the Society of Thoracic Surgery, Weber, et al., of Switzerland offered the…

Landmark Clinical Research

Research with the On-X Heart Valve in a poorly anticoagulated South African patient group to be presented at major US Heart Centers Mervyn A. Williams, M.D., of Provincial Hospital in Port Elizabeth, South Africa, to present findings showing that the On-X valve may be able to adapt to fluctuations in anticoagulation with all types of…

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…

Highlighting 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…

On-X Heart Valve’s Exceptional Clinical Performance

Important Clinical Research Featuring the On-X Heart Valve to be Presented at The Biennial Meeting of the Society for Heart Valve Disease in Barcelona, Spain AUSTIN, Texas, Jun 27, 2011 (BUSINESS WIRE) — On-X(R) Life Technologies, Inc. (On-X LTI) announced today that four clinical trial reports, documenting the On-X(R) Prosthetic Heart Valve’s extraordinary performance, will be presented at the upcoming meeting of the Society for Heart Valve Disease in Barcelona, Spain being held June 25-28, 2011. The reports will include interim clinical results from the Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT), which is being conducted in 36 major institutions in the United States, a comparison of the On-X heart valve with three competitive mechanical valves in Australia, a Ten-year Multiple Center European Study and a Ten-year Study in Poorly Controlled Anticoagulated Patients in South Africa