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Artivion Announces Presentation of New Clinical Data from NEXUS TRIOMPHE IDE Trial at the 105th American Association for Thoracic Surgery (AATS) Annual Meeting

1. Artivion presented positive data from the NEXUS TRIOMPHE trial. 2. 63% reduction in major adverse events compared to performance goals. 3. NEXUS device shows significant improvement in clinical outcomes. 4. Minimally invasive option for high-risk aortic dissection patients. 5. One-year outcomes are anticipated after initial 30-day results.

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Why Bullish?

The positive trial results suggest heightened investor confidence, akin to similar advancements benefitting companies like Medtronic in the past.

How important is it?

The article directly discusses clinical outcomes impacting AORT's product offerings and future market position.

Why Long Term?

The NEXUS device could redefine treatment standards in aortic diseases, leading to sustained growth if outcomes remain favorable.

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30-Day Data from Endospan's NEXUS TRIOMPHE IDE Trial Demonstrate 63% Reduction in Major Adverse Event (MAE) Rate compared with Reference Performance Goal , /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 Endospan's NEXUS TRIOMPHE trial at the 105th American Association for Thoracic Surgery (AATS) Annual Meeting in Seattle, Washington. The data presented analyzed clinical outcomes across a 54-patient chronic aortic dissection statistical cohort at 30 days following treatment with NEXUS.  Patients enrolled were at high risk for open surgical repair. Dr. Bradley Leshnower, Professor of Surgery and Director of Thoracic Aortic Surgery, Emory University, presented the data from the NEXUS US IDE trial in an abstract titled, Endovascular Aortic Arch Repair Using a Novel Single-Branch Arch Stent Graft for Chronic Dissection: 30-Day Outcomes of the TRIOMPHE FDA Pivotal Study. The data demonstrate statistically significant improvement in clinical outcomes and device technical performance compared with the performance goals set forth in the FDA-approved investigational device exemption (IDE). TRIOMPHE  Performance Goal p Value MAEs* >=1 13.0 % 35.0 % p <0.001 Technical Failure 1.9 % 30.0 % p <0.001 *Major adverse events (MAEs) = mortality, disabling stroke, permanent paralysis/paraplegia, renal failure, aortic rupture, or development of new dissections in the thoracic aorta or brachiocephalic artery requiring intervention. Dr. Leshnower said, "The 30-day results from the TRIOMPHE study demonstrate that aneurysms due to chronic aortic arch dissection involving the aortic arch can be successfully treated with this novel off-the-shelf stent graft system.  The NEXUS device provides an excellent, minimally invasive alternative to open aortic arch replacement in select patients at high risk for open surgery. This novel technology will extend treatment to patients who previously would not be offered therapy due to prohibitive risk" "We are pleased with the 30-day results and look forward to seeing the one-year outcomes," said Pat Mackin, Chairman, President and Chief Executive Officer of Artivion. "These results further validate this important therapeutic option for patients with aortic arch disease." About the NEXUS TRIOMPHE Clinical TrialThe 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 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. References Leshnower B: Endovascular Aortic Arch Repair Using a Novel Single-Branch Arch Stent Graft for Chronic Dissection: 30-Day Outcomes of the TRIOMPHE FDA Pivotal Study.  Presented May 3, 2025 at American Association of Thoracic Surgeons 105th annual meeting. Contacts: Artivion          Lance A. Berry                                               Executive Vice President & Chief Financial Officer Phone: 770-419-3355 Gilmartin Group LLC Brian Johnston / Laine Morgan Phone: 332-895-3222 [email protected]  SOURCE Artivion, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In

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