Artivion, Inc. (AORT) announced that the U.S. FDA has granted premarket approval for the NEXUS Aortic Arch System, a minimally invasive stent graft designed to treat complex aortic arch disease, including chronic dissections.
This approval makes NEXUS the first branched endovascular stent graft cleared for use in the United States, offering patients a safer alternative to open-chest surgery.
The FDA's decision was supported by data from the NEXUS TRIOMPHE IDE trial, which demonstrated 90% patient survival from lesion-related death, 90% freedom from disabling stroke at one-year post treatment, and 98% freedom from reintervention due to endoleaks at one year in a high-risk patient population.
The NEXUS system was previously granted CE Mark approval in Europe, where it has been used in patients with complex aortic arch disease. With the U.S. approval, Artivion expands access to this therapy for American patients while strengthening its global footprint.
The approval also entitles Artivion to exercise its option to acquire Endospan Ltd. within 90 days, supported by a $150 million delayed draw term loan, secured in anticipation of this milestone.
"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."
This FDA nod represents a major step forward for Artivion as it continues to expand its portfolio of advanced cardiac and vascular solutions worldwide.
AORT has traded between $21.97 and $48.25 over the past year. The stock closed Monday's trading at $33.45, down 2.11%. In pre-market trading the stock is at $34.00, up 1.58%.
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