Artivion Announces Presentation of Positive New Clinical Data from NEXUS TRIOMPHE and AMDS PERSEVERE Trials at the 62nd Society of Thoracic Surgery Annual Meeting

The NEXUS TRIOMPHE IDE trial presentation of 94 patients highlighted 94% patient survival from lesion related death and 91% freedom from disabling stroke at 1-year post-treatment in this high-risk patient group. The data also showed 97% of patients were free from reintervention due to endoleaks with no occurrence of renal failure and one occurrence of paraplegia out to 1-year post-implant. Meanwhile, data from the AMDS PERSEVERE IDE trial demonstrated positive aortic remodeling, minimal morbidity, and zero distal anastomotic new entry (DANE) tears between 1- and 2-year follow-up.

"We are pleased with the 1-year outcomes from the NEXUS TRIOMPHE trial and continued positive results from the AMDS PERSEVERE trial which further validate these important therapeutic options for patients with aortic arch disease," said Pat Mackin, Chairman, President, and Chief Executive Officer at Artivion.

1-Year Data from NEXUS TRIOMPHE IDE Trial:
The abstract titled "An Off the Shelf Solution for Chronic Dissections Involving the Aortic Arch: One Year Results of the NEXUS Aortic Arch System" reports 1-year of clinical follow-up on all 94 enrolled patients who were treated with NEXUS for chronic dissection, aneurysm, or other arch disease. The enrolled patients were at high risk for open surgery, as evidenced by ASA risk class III¹ (40%) and IV² (57%). The results demonstrate positive benefits out to 1-year:

• 94% patient survival from lesion related death in this high-risk study population,
• 91% of patients were free from disabling stroke,
• No reinterventions for loss of device integrity, device migration or aortic rupture,
• 97% of patients were free from reintervention due to endoleaks; and
• No thrombus formation in the integrated brachiocephalic trunk (BCT) branch.

¹ASA class III is defined as severe systemic disease with definite functional limitation
²ASA class IV is defined as severe systemic disease that is a constant threat to life

Dr. Himanshu Patel, Professor of Cardiac Surgery and Head of the Section of Adult Cardiac Surgery, University of Michigan, who presented the study results, said, "The 1-year results from the TRIOMPHE study signal a promising path forward for aortic arch treatment with this novel off-the-shelf endovascular stent graft system."

2-Year Data from AMDS PERSEVERE IDE Trial:
The abstract titled "Using a Novel Hybrid Aortic Arch Prosthesis for Open Repair of Acute DeBakey Type I Dissection with Malperfusion: Two-Year Results from the PERSEVERE Trial" reports noteworthy clinical and radiographic outcomes on 93 study participants following 1- and 2-year of clinical and radiographic follow-up. The data continue to demonstrate the clinical benefit of AMDS after 1-year: 

• Minimal additional mortality, limited to 4 deaths due to unrelated cause,
• No additional unanticipated aortic reoperation, remaining at 4.3%,
• Continued absence of DANE tears,
• Stable total aortic diameter in aortic zones 1-6 (aortic arch to upper abdomen), with a mean change of <2mm and continued mean true lumen diameter expansion up to 1.7 mm; and

Dr. Kyle Eudailey, Associate Professor at the University of Alabama at Birmingham said, "The 2-year results from the PERSEVERE trial continue to show excellent clinical and radiographic outcomes, demonstrating that AMDS is an important tool in the treatment of acute DeBakey Type I aortic dissection."

About the NEXUS TRIOMPHE Clinical Trial
The NEXUS TRIOMPHE trial is the US IDE study evaluating the NEXUS device in the endovascular treatment of chronic aortic dissection, either primary type B or residual dissection after prior type A repair, or aneurysm (not reported here). Inclusion criteria include the patient being high risk for open surgical repair. The clinical module of the PMA is anticipated to be filed after completion of one year of follow up with the 54 patients in the chronic aortic dissection statistical primary cohort.

About the AMDS PERSEVERE Clinical Trial
The PERSEVERE trial is a prospective, multicenter, non-randomized clinical trial to determine if patients with acute DeBakey Type I aortic dissection can be treated safely and effectively using the AMDS Hybrid Prosthesis. The trial was designed to support the Company's application for premarket approval (PMA) of the AMDS that is currently under review by the U.S. Food and Drug Administration (FDA). The trial consists of 93 participants in the U.S., who have experienced an acute DeBakey Type I aortic dissection complicated by malperfusion. Each participant will be followed for up to 5 years. 30-day trial data met combined safety and primary efficacy endpoints, demonstrating significant reduction of major adverse events (MAEs), including all-cause mortality, stroke, renal failure requiring dialysis, and myocardial infarction, and distal anastomotic new entry (DANE) tears following AMDS implantation. The secondary endpoint relates to remodeling of the aorta.

About Artivion, Inc.
Headquartered in suburban Atlanta, Georgia, Artivion, Inc., is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion's four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion markets and sells products in more than 100 countries worldwide. For additional information about Artivion, visit our website, www.Artivion.com.

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SOURCE Artivion, Inc.