Artivion, Inc. announced the presentation of new clinical data from Endospan's NEXUS TRIOMPHE IDE trial and its AMDS PERSEVERE IDE trial at the 62nd Annual Meeting of the Society of Thoracic Surgery in New Orleans, Louisiana. 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. 1-year Data from NEXUS TRIOMPH EVERE 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%). 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. 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 The NEXUS TRIOM PHE trial is the US IDE study evaluating the NEXUS device in the endovascular treatment of acute DeBakey Type I aortic dissection, either primary type B or residual dissection after prior type A repair, or aneurysm (not reported here). The PERSEVERE trial is a prospective, multicenter, non-randomized clinical trial to determine if patients with acute DeBakey TypeI 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 expected to be in the second half of 20 years.
Artivion, Inc. is engaged in manufacturing, processing, and distribution of medical devices and implantable human tissues used in cardiac and vascular surgical procedures for patients with aortic disease. The Company operates through two segments, which include Medical Devices and Preservation Services. The medical devices and preservation services are primarily used by cardiac and vascular surgeons to treat patients with aortic disease, including heart valve disease, aortic aneurysms, and dissections, and, to a lesser extent, other conditions in cardiac and vascular surgery. It has four product families: aortic stent grafts, On-X mechanical heart valves and related surgical products, surgical sealants, and implantable cardiac and vascular human tissues. Its aortic stent grafts include aortic arch stent grafts, abdominal stent grafts, and synthetic vascular grafts. Its surgical sealants include BioGlue Surgical Adhesive products.
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