On-X Life Technologies has announced today that its previously CE-marked On-X prosthetic heart valve has received European regulatory approval for an expanded labelling claim, which now permits the company to market its valve with a reduced requirement for the use of blood-thinning drugs such as warfarin. A press release reports that branded On-X Plus 1.5 aortic heart valve is now the only heart valve that allows patients to be managed at INR levels as low as 1.5.
According to the press release, the expanded labelling claim was supported by interim data from a recently completed arm of an FDA IDE clinical trial—Prospective randomized 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 prosthetic heart valve patients on a reduced anticoagulation therapy regimen while decreasing bleeding complications by more than 50%.
“It changes our perspective on how patients can be managed if they have an On-X mechanical valve with respect to their wafarin or coumadin dose,” says Marc Gerdisch, cardiac surgeon, PROACT investigator. “We have always known that most people age 65 or younger should be treated with a mechanical valve. Now we recognise that the On-X valve provides the additional advantage of being able to maintain the blood thinner at a lower dose, and in fact improve safety, because the incidence of bleeding events is less.”