Artivion Announces Treatment of First Patient with Arcevo LSA in ARTIZEN Pivotal Trial

Artivion (NYSE: AORT) announced the first patient has been treated in the ARTIZEN pivotal trial evaluating the Arcevo LSA Hybrid Stent Graft System for acute and chronic aortic arch pathologies.

Rhea-AI Summary

Artivion (NYSE: AORT) announced the first patient has been treated in the ARTIZEN pivotal trial evaluating the Arcevo LSA Hybrid Stent Graft System for acute and chronic aortic arch pathologies. The prospective, multicenter, non-randomized study will enroll 132 participants across up to 30 U.S. and European centers, with follow-up to five years and emphasis on 1-year outcomes. Primary combined safety and efficacy endpoints include all-cause mortality, new permanent disabling stroke, new permanent paraplegia/paraparesis, unanticipated aortic reoperation in the treated segment, and left subclavian artery occlusion. Artivion says the trial is intended to support a U.S. PMA submission and estimates an incremental $80 million U.S. market opportunity for Arcevo as soon as 2029.

Positive

• First patient treated in ARTIZEN pivotal trial
• Trial to enroll 132 patients across up to 30 centers
• Study supports a planned PMA submission in the U.S.
• Company estimates an incremental $80M U.S. market opportunity by 2029

Negative

• Trial is non-randomized, which may limit comparative evidence strength
• PMA and commercial upside are contingent on trial success and timing to 2029

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ATLANTA, Nov. 6, 2025 /PRNewswire/ -- Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced the treatment of the first patient in the ARTIZEN pivotal trial, evaluating the safety and effectiveness of the Arcevo™ LSA Hybrid Stent Graft System ("Arcevo LSA") in the treatment of acute and chronic arch pathologies. The trial is designed to support the Company's forthcoming application to the U.S. Food and Drug Administration (FDA) for Premarket Approval (PMA) of Arcevo LSA.

The ARTIZEN trial is a prospective, multicenter, non-randomized clinical trial consisting of 132 participants in the U.S. and Europe at up to 30 centers, who have experienced aortic dissection or aneurysm in the aortic arch. Each participant will be followed for up to five years, with a focus on 1-year outcomes. The combined primary safety and efficacy endpoints will determine the impact of Arcevo LSA on reducing all-cause mortality, new permanent disabling stroke, new permanent paraplegia or paraparesis, unanticipated aortic reoperation in the treated segment, and left subclavian artery (LSA) occlusion.

Dr. Eric Roselli, the ARTIZEN Global Principal Investigator, Chief of Adult Cardiac Surgery at the Cleveland Clinic Department of Thoracic and Cardiovascular Surgery, said "Surgery for aortic arch disease is complex, particularly when connecting to the left subclavian artery because of its anatomic location deep in the chest. The Arcevo device is a major advancement that may streamline the operation, making it faster and potentially safer for the patient."

"We are excited to see the first patient be enrolled in the Arcevo IDE trial which represents a positive milestone for the Company, and we look forward to bringing our next generation frozen elephant trunk to more patients in need through the ARTIZEN pivotal trial," said Pat Mackin, Chairman, President and Chief Executive Officer of Artivion. "We estimate a PMA for Arcevo would open an incremental $80 million U.S. market opportunity as soon as 2029."

About the Arcevo LSA ARTIZEN Pivotal Trial
The ARTIZEN trial is a prospective, multicenter, non-randomized clinical trial evaluating the safety and effectiveness of Arcevo LSA in the treatment of acute and chronic aortic arch pathologies. The trial is designed to support the Company's forthcoming application to the U.S. Food and Drug Administration (FDA) for Premarket Approval (PMA) of Arcevo LSA. The trial consists of 132 participants in the U.S. and Europe, who have experienced aortic dissection or aneurysm. Each participant will be followed for up to five years. The combined primary safety and efficacy endpoints will determine the impact of Arcevo LSA on reducing all-cause mortality, new permanent disabling stroke, new permanent paraplegia or paraparesis, unanticipated aortic reoperation in the treated segment, and LSA occlusion.

About the Arcevo™ LSA Hybrid Stent Graft System
Arcevo LSA comprises of a self-expanding aortic stent graft with an integrated stented left subclavian artery (LSA) branch, preloaded onto a delivery system engineered for controlled and accurate deployment of the implant into the transected aorta and LSA during a Frozen Elephant Trunk (FET) procedure. Arcevo LSA is the Company's next generation FET device, building on the E-vita^® Open Neo Hybrid Stent Graft System, currently available in Europe and Asia.

The FET procedure is a hybrid surgical approach that combines open surgery with an endovascular stented device to treat extensive aortic disease. The stented LSA branch of the Arcevo LSA device is designed to simplify one of the most challenging steps of the procedure by allowing surgeons to perform a more proximal repair with the main anastomosis in zone 2 and eliminating the need for an LSA anastomosis. This innovative design is intended to reduce circulatory arrest time, minimize bleeding and nerve injury, and ultimately improve patient outcomes in complex aortic arch repair¹.

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. Roselli et al. Branched stented anastomosis frozen elephant trunk repair: Early results from a physician-sponsored investigational device exemption study. JTCVS 2024 September; 168,3:746-756.

Contacts:
Artivion	Gilmartin Group LLC
Lance A. Berry	Brian Johnston
Executive Vice President,	Laine Morgan
Chief Operating Officer &	Phone: 332-895-3222
Chief Financial Officer	investors@artivion.com
Phone: 770-419-3355

 

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SOURCE Artivion, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is the ARTIZEN pivotal trial for Artivion (AORT)?

The ARTIZEN trial is a prospective, multicenter, non-randomized study of 132 patients evaluating Arcevo LSA for aortic arch dissection and aneurysm with up to 5 years follow-up.

When did Artivion (AORT) treat the first patient in the ARTIZEN trial?

Artivion announced the first patient was treated on November 6, 2025.

What are the primary endpoints of the ARTIZEN trial for Arcevo LSA (AORT)?

Combined safety and efficacy endpoints include all-cause mortality, new permanent disabling stroke, paraplegia/paraparesis, unanticipated aortic reoperation in the treated segment, and LSA occlusion.

How many centers and regions are participating in the ARTIZEN trial for Artivion (AORT)?

The trial will enroll patients at up to 30 centers across the U.S. and Europe.

What commercial impact does Artivion forecast from an Arcevo PMA (AORT)?

Artivion estimates an incremental $80 million U.S. market opportunity for Arcevo as soon as 2029 if a PMA is achieved.