Artivion Announces Presentation of New Clinical Data for On-X Aortic Heart Valve and AMDS at the 104th American Association for Thoracic Surgery (AATS) Annual Meeting

In This Article:

5-Year Real-World Safety and Efficacy Data from On-X Aortic Heart Valve Low INR Post-Market Study Demonstrate Even Better Patient Outcomes Than Predicted by the PROACT IDE Study

Late-Breaking 30-Day Data from AMDS PERSEVERE Trial Demonstrate Positive Aortic Remodeling Outcomes and Zero DANE Tears

ATLANTA, April 29, 2024 /PRNewswire/ -- Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today 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 (AATS) Annual Meeting in Toronto, Canada.

(PRNewsfoto/Artivion, Inc.)
(PRNewsfoto/Artivion, Inc.)

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 (DANE) tears.

5-Year Real-World Safety and Efficacy Data from On-X Aortic Heart Valve Low INR Post-Market Study:

Dr. Marc Gerdisch, Chief of Cardiothoracic Surgery at Franciscan St. Francis Health in Indianapolis, IN, presented an abstract titled, Low-Dose Warfarin with a Novel Mechanical Aortic Valve: Interim Registry Results at 5-Year Follow-up. The abstract reported five years of clinical follow-up on 229 study participants with a target INR of 1.8 (range 1.5-2.0). Results show a significantly lower composite primary endpoint of thromboembolism, valve thrombosis, and major bleeding (linearized occurrence rate (LOR) of 1.83% compared to the pre-defined historic control rate of 5.39% (p<0.0001)), driven by an 87% reduction in major bleeding and no increase in thromboembolism compared to historic control group of standard dose warfarin (2.0-3.0).

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. A key aspect of this post market study is the real-world representation of patient INR monitoring, where the majority (84%) of On-X recipients underwent INR monitoring at a clinic rather than at home, whereas 100% patients in the PROACT IDE study were managed using home INR monitoring.