Artivion presents new clinical data for On-X Aortic Heart Valve and AMDS

Artivion announced the presentation of new clinical data from the On-X Low INR post-market study and AMDS PERSEVERE Trial at the 104th American Association for Thoracic Surgery Annual Meeting in Toronto. Presentations highlighted 5-year real-world safety and efficacy data from the On-X Aortic Heart Valve Low INR post-market study that demonstrate even better patient outcomes than predicted by the On-X Aortic Heart Valve PROACT IDE Study, as well as Late-Breaking data from the AMDS PERSEVERE Trial demonstrating, at 30-days post-AMDS implantation, positive aortic remodeling outcomes and zero distal anastomotic new entry tears. Results show a significantly lower composite primary endpoint of thromboembolism, valve thrombosis, and major bleeding of 1.83% vs. the pre-defined historic control rate of 5.39%, driven by an 87% reduction in major bleeding and no increase in thromboembolism compared to historic control group of standard dose warfarin. These real-world interim results confirm that the On-X Aortic Valve remains safe and effective with low-dose warfarin and reflect even better patient outcomes compared to those in the On-X Aortic Heart Valve Low INR Post-Market Study 1-year results presented in 20231, and the On-X Aortic Low INR IDE Study first published in 20142. Early Results of the PERSEVERE Study suggest positive aortic remodeling after treatment with the AMDS Hybrid Prosthesis, as well as no occurrence of distal anastomotic new entry tears.