On-X Life Technologies has been granted European regulatory approval for an expanded labeling claim for its previously CE-marked On-X prosthetic heart valve.
With this approval, the company can now sell its mechanical aortic heart valve in Europe with a reduced requirement for the use of blood-thinning drugs such as warfarin.
On-X Life Technologies claims that the newly branded On-X Plus 1.5 aortic heart valve is now the only heart valve that allows patients to be managed at International Normalized Ratio levels as low as 1.5, a near-normal level.
The expanded labeling claim was based on interim data from the recently completed Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT), a FDA IDE clinical trial, demonstrating the safety of maintaining On-X prosthetic heart valve patients on a reduced anticoagulation therapy regimen while decreasing bleeding complications by more than 50%.
On-X Life Technologies president and CEO Clyde Baker noted this is a significant medical advance for aortic heart valve patients in Europe.
"In the past, the primary concern related to mechanical heart valves had been the requirement for complementary anticoagulation therapy despite its well-documented risk of bleeding.
"Now, On-X Plus 1.5 Aortic Valve recipients in Europe will be able to take a lower level of anticoagulant that will reduce the potential incidence of bleeding complications caused by taking the higher dosages normally prescribed after receiving a mechanical heart valve. We will commence marketing efforts with our new labeling claim immediately," Baker added.
According to the company, the On-X heart valve is the result of a breakthrough in medical grade carbon technology: On-X pure pyrolytic carbon. The device provides more thromboresistant surface.
The high strength of pure On-X Carbon has enabled On-X LTI to make significant valve design changes that have resulted in a prosthesis that acts more like a natural valve in its treatment of blood.
In clinical studies, On-X valve has been found that it does not produce the turbulence and blood damage and significantly reduces the potential for life-threatening blood clots.
Based on these results, On-X valve has been granted the expanded labeling claim in the EU.