On-X Life Technologies announced that it has assembled its European sales force at a training symposium in Barcelona ahead of launching its international marketing campaign for the On-X Plus 1.5 aortic heart valve.
In January, On-X Life Technologies received European regulatory approval for an expanded labelling claim, which now permits the company to market its 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 international normalised ratio range between 1.5—2.0, a near-normal level.
The European expanded labelling claim was supported by interim data from a recently completed arm of a US Food and Drug Administration investigational device exemption clinical trial—Prospective Randomised On-X Anticoagulation clinical trial (PROACT)—presented by principal investigator John D Puskas, Cardiothoracic Surgery, Emory University, Atlanta, USA, at the annual scientific meeting of the American Association for Thoracic Surgery (AATS). These data demonstrated the safety of maintaining On-X aortic heart valve patients on a reduced anticoagulation therapy regimen while decreasing bleeding complications by 60%.
“We fully expect that our On-X Plus 1.5 aortic heart valve will be rapidly and broadly embraced by heart surgeons throughout Europe, not only by our current customers but also by new surgeons who want the best mechanical valve for their patients, because the On-X valve is the only mechanical valve with a clinically established 60% reduction in bleeding events with no increase in thromboembolic events at the lower warfarin dosage in the PROACT clinical trial, an FDA-approved multicentre study with over 1,400 patient years and 50,000 international normalised ratio data points,” says Clyde Baker, president and chief executive officer of On-X Life Technologies.