February 10, 2014 — On-X Life Technologies Inc. received CE marking for an expanded labeling claim of its On-X Prosthetic Heart Valve. The company may market its mechanical heart valve in Europe with areduced requirement for the use of blood-thinning drugs such as warfarin. The On-X Plus 1.5 Aortic Heart Valve allows patients to be managed at INR (international normalized ratio) levels as low as 1.5.
The expanded labeling claim was supported by interim data from a recently completed arm of an U.S. Food and Drug Administration (FDA) IDE clinical trial, “Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT).” Principal Investigator John D. Puskas, M.D., cardiothoracic surgery, Emory University, Atlanta, presented results at the annual scientific meeting of the American Association for Thoracic Surgery (AATS). These data demonstrated the safety of maintaining On-X Prosthetic Heart Valve patients on a reduced anticoagulation therapy regimen while decreasing bleeding complications by more than 50 percent.
The On-X heart valve is the result of a medical grade carbon technology: On-X pure pyrolytic carbon. In addition to providing a more thromboresistant surface, the comparatively high strength of pure On-X Carbon has enabled On-X LTI to make valve design changes that have resulted in a prosthesis that acts more like a natural valve in its treatment of blood. Clinical studies have documented that the On-X valve does not produce the turbulence and blood damage commonly produced by other mechanical heart valve prostheses and, therefore, significantly reduces the potential for life-threatening blood clots.
This therapy is not approved in the United States or other countries that have reviews independent of the European Union. In these countries On-X Life Technologies Inc., continues to recommend standard anticoagulation therapy as presently prescribed by various professional societies for the On-X valve. On-X aortic and mitral valves are FDA approved.
For more information: www.onxlti.com