On-X Life Technologies has 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, 10 March to 12 March 2014, Edinburgh, Scotland.
In January, On-X LTI received European regulatory approval for an expanded labeling 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 INR (International Normalized Ratio) levels as low as 1.5 — 2.0. An INR blood test measures the time it takes for patients’ blood to clot.
On-X LTI president and CEO Clyde Baker noted the company is extremely pleased with the market’s eagerness to embrace its On-X Plus 1.5 valve.
"In Europe the On-X aortic valve is unique among all other mechanical valves and also offers a new option to patients in their 50s and 60s who are considering a tissue valve. These patients are expected to live an additional 20 years. Tissue valve failure is documented to occur between eight to 16 years post-implant.
"Replacement valve surgery will be necessary for these patients when they are in their 70’s and 80’s. Now that it has been shown to be safe to use the On-X mechanical valve with low levels of warfarin, these patients and their surgeons have a new valve option available, and the early response of clinicians has been very encouraging," Baker added.
The European expanded labeling 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). The data demonstrated the safety of maintaining On-X aortic heart valve patients on a reduced anticoagulation therapy regimen while decreasing bleeding complications by 60%.
The On-X heart valve is the result of a breakthrough in 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 significant 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, which is the basis of the expanded labeling claim recently granted to On-X LTI in the EU.