On-X Life Technologies announced that it will launch its European marketing campaign for the On-X Plus 1.5 aortic heart valve in concert with its Great Britain distributor Vascutek at the Annual Meeting & Cardiothoracic Forum of the Society for Cardiothoracic Surgery in Great Britain & Ireland, March 10-12, Edinburgh, Scotland.
In January, On-X LTI received European regulatory approval for an expanded labelling claim, which now permits the company to market its breakthrough mechanical heart valve in Europe with a reduced requirement for the use of anticoagulants (warfarin). The On-X Plus 1.5 aortic heart valve is the only heart valve that allows patients to be managed at international normalised ratio levels as low as 1.5—2.0.
“Europe has been waiting for just such guidance from a leading mechanical valve producer, and we are very happy to see On-X take this lead with the new labelling on its product,” says John McKenna, Vice President of Cardiothoracic Business Development for Vascutek, a subsidiary of Terumo Corporation. “Cardiac surgeons in the UK immediately presented us with an order on hearing of or catching sight of the new labelling. We are very excited by the prospects for patients, surgeons and hospitals.”
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 in 2013. 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%.