Endospan's NEXUS branched endovascular stent graft system shown to effectively treat aortic arch disease, including chronic aortic dissections
ATLANTA, April 7, 2026 /PRNewswire/ -- Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced that the U.S. Food and Drug Administration (FDA) has approved the premarket approval application (PMA) for the NEXUS® Aortic Arch System, developed by Endospan Ltd. ("Endospan"), Artivion's long-standing partner. The approval entitles Artivion to exercise its option to acquire Endospan at any time within 90 days of receiving this notice of FDA approval. Artivion has a $150 million delayed draw term loan in place, secured in anticipation of this approval, to fund a potential acquisition. The Company is actively working to complete its evaluation of the option following the earlier than anticipated approval.
NEXUS is a branched endovascular stent graft system approved in the United States for the minimally invasive treatment of aortic arch disease, including chronic aortic dissections, a patient population that has historically had little treatment option but open-chest surgery. The FDA's approval is supported by data from the NEXUS TRIOMPHE IDE trial, which demonstrated 90% patient survival from lesion-related death, 90% freedom from disabling stroke at 1-year post treatment, and 98% freedom from reintervention due to endoleaks at one year in a high-risk patient population.
"NEXUS receiving FDA approval ahead of our expectations is an exciting milestone for patients with aortic arch disease, for our partner Endospan, and for Artivion," said Pat Mackin, Chairman, President, and Chief Executive Officer. "The TRIOMPHE data has consistently demonstrated the clinical value of this technology, and we are proud to have supported Endospan on this journey. We have proactively put the financing in place to support a potential acquisition, and we are moving diligently to finalize our considerations around the option. We look forward to updating shareholders soon."
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.
About Endospan Ltd.
Privately held Endospan, headquartered in Herzliya (Tel Aviv), Israel, is a pioneer in the endovascular repair of Aortic Arch Disease including aneurysms and dissections. Endospan has received CE-Mark to commercialize in Europe the NEXUS Stent Graft System, the first endovascular off-the-shelf system to treat Aortic Arch Disease which affects a greatly underserved group of patients diagnosed with a dilative lesion in, or near, the aortic arch. While minimally invasive endovascular repair has been the standard of care for Abdominal Aortic Aneurysm (AAA), Aortic Arch Disease patients with aneurysms or dissections have not been as fortunate and have had little choice but to undergo open-chest surgery with its invasiveness and risks, lengthy hospitalization periods, and prolonged recuperation. For additional information about Endospan, visit their website, www.endospan.com.
Contact:
Artivion | Gilmartin Group LLC |
Lance A. Berry | Brian Johnston |
Executive Vice President, | Phone: 332-895-3222 |
Chief Operating Officer & | [email protected] |
Chief Financial Officer | |
Phone: 770-419-3355 |
SOURCE Artivion, Inc.
