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

Rhea-AI Summary

Artivion (NYSE: AORT) presented promising clinical data from Endospan's NEXUS TRIOMPHE IDE trial at the 105th AATS Annual Meeting. The study evaluated 54 high-risk patients with chronic aortic dissection treated with the NEXUS stent graft system. At 30 days post-treatment, the results showed a significant 63% reduction in Major Adverse Events (MAE) rate at 13.0% compared to the 35.0% performance goal (p<0.001). The technical failure rate was notably low at 1.9% versus the 30.0% performance goal (p<0.001). The NEXUS device represents a minimally invasive alternative to open aortic arch replacement for high-risk patients, potentially extending treatment options to previously untreatable cases.

Positive

• Significant 63% reduction in Major Adverse Events rate (13.0% vs 35.0% performance goal)
• Extremely low technical failure rate of 1.9% vs 30.0% performance goal
• Potential market expansion by offering treatment to high-risk patients previously considered untreatable

Negative

• None.

Insights

Medical Device Expert

Artivion's NEXUS device shows impressive 63% reduction in major adverse events for aortic arch repair, potentially expanding treatment to high-risk patients.

The NEXUS TRIOMPHE IDE trial results show remarkably positive outcomes for a challenging cardiovascular condition. With a 63% reduction in major adverse events (13.0% versus 35.0% performance goal, p<0.001), this novel single-branch arch stent graft system demonstrates significant clinical improvement for patients with chronic aortic dissection. Even more impressive is the technical failure rate of just 1.9% compared to the 30.0% performance goal (p<0.001).

What makes these results particularly meaningful is their application in high-risk patients who would otherwise have limited options. Traditional open aortic arch replacement is an extremely complex procedure with substantial surgical risks including stroke, paralysis, and mortality. The NEXUS device provides a minimally invasive alternative that appears significantly safer based on this 54-patient cohort.

The highly statistical significance (p<0.001) for both endpoints suggests these improvements are real rather than random variation. This off-the-shelf system addresses a specific unmet need in aortic arch disease, potentially extending treatment to patients previously considered inoperable due to prohibitive surgical risk.

While these 30-day results are encouraging, long-term durability remains critical for endovascular devices treating the aortic arch - a region subject to significant hemodynamic forces. The upcoming one-year outcomes will be essential for establishing sustained efficacy and device integrity over time, but these early results certainly validate the approach and technology.

Healthcare Financial Analyst

Statistically significant clinical trial results strengthen NEXUS device's path to potential FDA approval, expanding Artivion's addressable market in aortic disease.

These NEXUS TRIOMPHE trial results represent a significant milestone for Artivion's cardiovascular portfolio. The 63% reduction in major adverse events provides compelling clinical evidence that substantially exceeds the performance goals established for FDA evaluation. Both primary endpoints demonstrated highly significant p-values (<0.001), strengthening the case for eventual regulatory approval.

From a market perspective, this device addresses an underserved patient population with chronic aortic arch dissection who are poor candidates for open surgery. By offering a minimally invasive alternative with substantially better safety outcomes, Artivion could potentially expand its addressable market to include patients who previously had limited treatment options.

The aortic disease market represents a growing segment within cardiovascular devices, driven by aging populations and improved diagnostic capabilities. Artivion's strategic focus on this specialized area allows them to develop expertise and targeted solutions like NEXUS that address specific clinical challenges.

While these are 30-day results from a cohort of 54 patients, the statistical significance and magnitude of improvement over performance goals provide a positive signal for the program's trajectory. The upcoming one-year outcomes will be critical for confirming durability and maintaining this performance advantage.

If these positive results continue in longer-term follow-up, NEXUS could become an important growth driver for Artivion, complementing their existing product offerings in aortic disease and strengthening their competitive position in this specialized cardiovascular market segment.

30-Day Data from Endospan's NEXUS TRIOMPHE IDE Trial Demonstrate 63% Reduction in Major Adverse Event (MAE) Rate compared with Reference Performance Goal

ATLANTA, May 5, 2025 /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 105^th 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 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 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

1. 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 105^th 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 investors@artivion.com

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SOURCE Artivion, Inc.

FAQ

What are the key findings from Artivion's (AORT) NEXUS TRIOMPHE trial presented at AATS 2025?

The trial showed a 63% reduction in Major Adverse Events (13.0% vs 35.0% performance goal) and a 1.9% technical failure rate (vs 30.0% goal) in treating chronic aortic dissection patients at 30 days post-treatment.

How does the NEXUS stent graft system benefit high-risk aortic arch patients?

NEXUS provides a minimally invasive alternative to open aortic arch replacement for high-risk patients, making treatment possible for those previously considered too risky for traditional surgery.

What was the patient population size in the NEXUS TRIOMPHE IDE trial?

The trial analyzed clinical outcomes across a cohort of 54 patients with chronic aortic dissection who were at high risk for open surgical repair.

What are the Major Adverse Events (MAEs) measured in the NEXUS TRIOMPHE trial?

MAEs include mortality, disabling stroke, permanent paralysis/paraplegia, renal failure, aortic rupture, or development of new dissections in the thoracic aorta or brachiocephalic artery requiring intervention.