Artivion Announces Presentation of Positive New Clinical Data from NEXUS TRIOMPHE and AMDS PERSEVERE Trials at the 62nd Society of Thoracic Surgery Annual Meeting

Rhea-AI Summary

Artivion (NYSE: AORT) will present new clinical data at the 62nd Society of Thoracic Surgeons meeting showing favorable outcomes from two IDE trials. NEXUS TRIOMPHE (n=94) reported 94% survival from lesion-related death and 91% freedom from disabling stroke at 1 year. AMDS PERSEVERE (n=93) showed persistent aortic remodeling, zero distal anastomotic new entry tears through 2 years, and minimal additional morbidity.

Positive

• NEXUS TRIOMPHE: 94% patient survival from lesion-related death at 1 year
• NEXUS TRIOMPHE: 91% freedom from disabling stroke at 1 year
• NEXUS TRIOMPHE: 97% free from reintervention due to endoleaks at 1 year
• AMDS PERSEVERE: zero DANE tears between 1- and 2-year follow-up
• AMDS PERSEVERE: stable total aortic diameter (2 mm mean change) and mean true lumen expansion up to 1.7 mm

Negative

• AMDS PERSEVERE: 4 additional deaths described as unrelated through 2 years
• AMDS PERSEVERE: overall aortic reoperation rate remained at 4.3%

Key Figures

NEXUS TRIOMPHE sample size: 94 patients Survival from lesion-related death: 94% Freedom from disabling stroke: 91% +5 more

8 metrics

NEXUS TRIOMPHE sample size 94 patients High-risk aortic arch disease patients in IDE trial

Survival from lesion-related death 94% 1-year post-treatment in NEXUS TRIOMPHE high-risk cohort

Freedom from disabling stroke 91% 1-year outcomes in NEXUS TRIOMPHE trial

Freedom from endoleak reintervention 97% 1-year NEXUS TRIOMPHE results

AMDS PERSEVERE participants 93 study participants 1- and 2-year follow-up in AMDS PERSEVERE IDE trial

Additional deaths 4 deaths Between 1- and 2-year follow-up in AMDS PERSEVERE, unrelated causes

Unanticipated aortic reoperation rate 4.3% Remained unchanged through 2 years in AMDS PERSEVERE

True lumen diameter change up to 1.7 mm Mean expansion in aortic zones 1–6 with AMDS at 1–2 years

Market Reality Check

Price: $41.23 Vol: Volume 567,492 is 1.89x t...

high vol

$41.23 Last Close

Volume Volume 567,492 is 1.89x the 20-day average of 300,690, indicating elevated interest ahead of this update. high

Technical Price 40.77 is trading above the 200-day MA at 37.85, reflecting a pre-existing upward bias into the news.

Peers on Argus

Peers showed mixed moves: UFPT +3.05%, CNMD +1.40%, IART +0.91%, NVCR +0.24%, wh...

Peers showed mixed moves: UFPT +3.05%, CNMD +1.40%, IART +0.91%, NVCR +0.24%, while ENOV declined 2.82%. With no peers in the momentum scanner, AORT’s action appears more stock-specific.

Previous Clinical trial Reports

3 past events · Latest: May 05 (Positive)

Same Type Pattern 3 events

Date	Event	Sentiment	Move	Catalyst
May 05	NEXUS trial data	Positive	+1.9%	30-day NEXUS TRIOMPHE results beat major adverse event performance goals.
Oct 10	Multiple trial data	Positive	+1.9%	Positive AMDS DARTS, PERSEVERE, and NEOS outcomes at EACTS meeting.
Apr 29	On-X and AMDS data	Positive	+0.1%	Favorable 5-year On-X valve and AMDS PERSEVERE clinical results.

Pattern Detected

Clinical trial presentations have consistently been positive and followed by modest single-day gains.

Recent Company History

Recent clinical-trial news for Artivion has centered on strengthening evidence across its aortic portfolio. On Apr 29, 2024, new 5-year On-X valve and AMDS data highlighted safety and positive aortic remodeling. On Oct 10, 2024, late-breaking EACTS data from AMDS DARTS, PERSEVERE, and NEOS showed strong durability and malperfusion resolution. On May 5, 2025, NEXUS TRIOMPHE 30-day data in 54 high-risk patients demonstrated significantly lower major adverse events versus performance goals. Today’s 1–2 year results extend this favorable evidence base.

Historical Comparison

clinical trial

+1.3 %

Average Historical Move

Historical Analysis

Past clinical-trial updates for AORT led to average 1-day moves of about 1.31%, with consistently constructive data across its aortic portfolio.

Typical Pattern

Prior releases focused on 30-day and multi-year outcomes for NEXUS, AMDS, and On-X. The current 1- and 2-year NEXUS TRIOMPHE and AMDS PERSEVERE data extend this trajectory of durable safety and aortic remodeling benefits.

Market Pulse Summary

This announcement adds longer-term evidence for Artivion’s NEXUS TRIOMPHE and AMDS PERSEVERE program...

Analysis

This announcement adds longer-term evidence for Artivion’s NEXUS TRIOMPHE and AMDS PERSEVERE programs, with high 1-year survival, low stroke and reintervention rates, and stable aortic dimensions out to 2 years. Prior clinical updates across NEXUS, AMDS, and On-X also showed favorable safety and remodeling outcomes, and historically produced modest single-day stock gains of about 1.31%. Investors may watch for further follow-up data and how these results translate into adoption and future regulatory milestones.

Key Terms

ide trial, endovascular

2 terms

ide trial regulatory

"Endospan's NEXUS TRIOMPHE IDE trial and its AMDS PERSEVERE IDE trial"

An IDE trial is a regulated clinical study that lets a company test a medical device in patients under an Investigational Device Exemption from the U.S. regulator; it’s essentially a formal permit to gather safety and effectiveness data before broad commercial approval. For investors, an IDE trial is a major de-risking step and milestone—successful results move a device closer to market approval and revenue, while delays or negative outcomes can materially affect a company’s value, similar to how a road-test permit lets a car maker prove a new model is safe before mass production.

endovascular medical

"off-the-shelf endovascular stent graft system"

Endovascular describes medical procedures performed inside blood vessels using thin tubes, wires, and implantable devices guided by imaging—like repairing a broken pipe from the inside rather than opening the wall. It matters to investors because these less-invasive techniques can shorten hospital stays, lower complication rates and create demand for specialized devices and imaging equipment, so changes in adoption, regulation or reimbursement can materially affect healthcare company revenues and margins.

AI-generated analysis. Not financial advice.

1-Year Data from Endospan's NEXUS TRIOMPHE IDE Trial Demonstrate High Patient Survival with Low Morbidity

2-Year Data from the AMDS PERSEVERE IDE Trial Further Demonstrate the Persistent Clinical Benefit of AMDS

ATLANTA, Feb. 2, 2026 /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 IDE trial and its AMDS PERSEVERE IDE trial at the 62^nd Annual Meeting of the Society of Thoracic Surgeons 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. The data also showed 97% of patients were free from reintervention due to endoleaks with no occurrence of renal failure and one occurrence of paraplegia out to 1-year post-implant. Meanwhile, data from the AMDS PERSEVERE IDE trial demonstrated positive aortic remodeling, minimal morbidity, and zero distal anastomotic new entry (DANE) tears between 1- and 2-year follow-up.

"We are pleased with the 1-year outcomes from the NEXUS TRIOMPHE trial and continued positive results from the AMDS PERSEVERE trial which further validate these important therapeutic options for patients with aortic arch disease," said Pat Mackin, Chairman, President, and Chief Executive Officer at Artivion.

1-Year Data from NEXUS TRIOMPHE 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%). The results demonstrate positive benefits out to 1-year:

• 94% patient survival from lesion related death in this high-risk study population,
• 91% of patients were free from disabling stroke,
• No reinterventions for loss of device integrity, device migration or aortic rupture,
• 97% of patients were free from reintervention due to endoleaks; and
• No thrombus formation in the integrated brachiocephalic trunk (BCT) branch.

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

Dr. Himanshu Patel, Professor of Cardiac Surgery and Head of the Section of Adult Cardiac Surgery, University of Michigan, who presented the study results, said, "The 1-year results from the TRIOMPHE study signal a promising path forward for aortic arch treatment with this novel off-the-shelf endovascular stent graft system."

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

Dr. Kyle Eudailey, Associate Professor at the University of Alabama at Birmingham said, "The 2-year results from the PERSEVERE trial continue to show excellent clinical and radiographic outcomes, demonstrating that AMDS is an important tool in the treatment of acute DeBakey Type I aortic dissection."

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 the AMDS PERSEVERE Clinical Trial
The PERSEVERE trial is a prospective, multicenter, non-randomized clinical trial to determine if patients with acute DeBakey Type I aortic 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 currently under review by the U.S. Food and Drug Administration (FDA). The trial consists of 93 participants in the U.S., who have experienced an acute DeBakey Type I aortic dissection complicated by malperfusion. Each participant will be followed for up to 5 years. 30-day trial data met combined safety and primary efficacy endpoints, demonstrating significant reduction of major adverse events (MAEs), including all-cause mortality, stroke, renal failure requiring dialysis, and myocardial infarction, and distal anastomotic new entry (DANE) tears following AMDS implantation. The secondary endpoint relates to remodeling of the aorta.

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.

Contacts:

Artivion          Lance A. Berry                                               Executive Vice President, Chief Operating Officer & 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 1-year results did Artivion report for NEXUS TRIOMPHE (AORT)?

The NEXUS TRIOMPHE 1-year results showed high survival and low stroke rates in high-risk patients. According to the company, 94% survived lesion-related death and 91% were free from disabling stroke at 1 year, with 97% free from reintervention for endoleaks.

What did the 2-year AMDS PERSEVERE (AORT) data show about aortic remodeling?

AMDS PERSEVERE demonstrated stable aortic anatomy and lumen improvement at 2 years. According to the company, total aortic diameter change averaged <2 mm and mean true lumen diameter expanded up to 1.7 mm, indicating persistent favorable remodeling.

Were there any device-related reinterventions or thrombus events reported in NEXUS TRIOMPHE (AORT)?

No device-integrity reinterventions or thrombus were reported in the NEXUS trial at 1 year. According to the company, there were no reinterventions for loss of device integrity, migration, or aortic rupture and no thrombus in the integrated BCT branch.

Did AMDS PERSEVERE (AORT) report any distal anastomotic new entry (DANE) tears at 2 years?

No DANE tears were reported between years 1 and 2 in the PERSEVERE trial. According to the company, the study continued to show an absence of distal anastomotic new entry tears at the 2-year follow-up.

What patient risk levels were enrolled in the NEXUS TRIOMPHE (AORT) study?

The TRIOMPHE cohort consisted predominantly of high surgical-risk patients. According to the company, 40% were ASA class III and 57% were ASA class IV, reflecting severe systemic disease and elevated operative risk in the enrolled population.