Artivion Presents Positive Real-World Data from On-X Aortic Heart Valve Low INR Study at EACTS Annual Meeting

Artivion, Inc., a leading cardiac and vascular surgery company focused on aortic disease, recently shared promising data from its On-X Aortic Heart Valve Low INR post-market study at the 37th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting in Vienna, Austria. The study, presented by Professor Aung Oo from Barts Heart Centre in London, England, demonstrated the safety and efficacy of the On-X Aortic Valve with low-dose warfarin.

The study included real-world data from 510 patients who underwent On-X Aortic Valve replacement and were treated with a lower-dose warfarin regimen. The results showed a significant reduction in the composite primary endpoint of thromboembolism, valve thrombosis, and major bleeding compared to a pre-defined historic control rate. The occurrence rate of the primary endpoint was 2.31% in the study group, compared to 5.39% in the control group (p<0.0001). This improvement in outcomes was driven by an 85% reduction in major bleeding and a 73% reduction in all bleeding. Professor Oo highlighted the challenges faced by patients undergoing heart valve replacement therapy, particularly the need for blood thinners and the associated risks. The study's long-term data demonstrated the clinical benefits of a lower-dose post-operative warfarin regimen, further supporting the use of On-X valves with low-dose warfarin. Artivion's Chairman, President, and CEO, Pat Mackin, expressed confidence in the safety and benefits of managing On-X aortic valve patients at a lower International Normalized Ratio (INR) compared to other mechanical valves. He emphasized that these findings reinforce the company's belief in On-X as a key component of their product portfolio. The On-X Aortic Valve is the only mechanical aortic heart valve that can be maintained at an INR of 1.5 to 2.0, as recommended in the American College of Cardiology/American Heart Association Guideline for the Management of Patients With Valvular Heart Disease. The On-X Aortic Low INR post-market study is a prospective, international, multi-center, observational study designed to assess the occurrence of adverse events with the On-X Aortic Prosthetic Valve when targeted at an INR level of 1.8 (1.5-2.0 range) during a 5-year follow-up period. The study's positive interim results further validate the safety and efficacy of the On-X Aortic Valve. Artivion, Inc. is a medical device company headquartered in Atlanta, Georgia, specializing in developing innovative solutions for cardiac and vascular surgeons treating patients with aortic diseases. Their product portfolio includes aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. With a global presence in over 100 countries, Artivion continues to make significant contributions to the field of cardiac and vascular surgery. For more information about Artivion and their products, please visit their website at www.artivion.com.