On-X Life Technologies announced that it will introduce the On-X Plus 1.5 Aortic Heart Valve and present the results of the PROACT clinical trial at a company-sponsored luncheon symposium during the upcoming annual scientific meeting of Asian Society for Cardiovascular and Thoracic Surgery (ASCVTS) in Istanbul as part of its international marketing campaign.
On-X has been successfully selling mechanical valves in International markets since July 1998.
In January, On-X LTI received European regulatory approval for an expanded labeling claim, which now permits the company to market its breakthrough mechanical heart valve in Europe with a reduced requirement for the use of blood-thinning drugs such as warfarin.
The On-X Plus 1.5 Aortic Heart Valve is the only approved mechanical heart valve that allows patients to be managed at an INR (International Normalized Ratio) range between 1.5 — 2.0. An INR blood test measures the time it takes for patients’ blood to clot.
On-X LTI president and CEO Clyde Baker said the company fully expects that its On-X Plus 1.5 Aortic Heart Valve will be rapidly and broadly embraced by heart surgeons throughout Europe and Asia, not only by our current customers but also by new surgeons who want the best mechanical valve for their patients.
"The On-X valve is the only mechanical valve with a clinically established 60% reduction in bleeding with no increase in thromboembolic events at the lower warfarin dosage in the PROACT clinical trial, an FDA-approved multicenter study with over 1,400 patient years and over 50,000 INR data points," Baker added.
"We have a long history of commitment to physicians and their patients who want the very best, safest mechanical valve available. Because it has been shown to be safe to use the On-X mechanical valve with low levels of warfarin, patients and their surgeons now have a new valve alternative, and the initial response from clinicians has been overwhelmingly positive."