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Artivion's Groundbreaking Milestone in Aortic Surgery

On November 6, 2025, Artivion, Inc., a prominent player in cardiac and vascular surgery, announced a significant milestone with the treatment of the first patient in the ARTIZEN pivotal trial. This trial is set to examine the safety and effectiveness of the Arcevo™ LSA Hybrid Stent Graft System, which holds promise for treating acute and chronic pathologies related to the aortic arch.

The ARTIZEN Pivotal Trial

The ARTIZEN trial is a prospective, multicenter, non-randomized clinical study. It includes 132 participants across the United States and Europe, specifically targeting individuals who have suffered from aortic dissection or aneurysm. Participants will be closely monitored for a duration of up to five years, with an emphasis on their outcomes after one year. The primary goals of the trial are to assess the combined safety and efficacy of the Arcevo LSA, focusing on critical factors such as:

• - Reduction in all-cause mortality
• - Prevention of new permanent disabling strokes
• - Minimization of paraplegia or paraparesis
• - Limitations on unanticipated reoperations in the treated segment
• - Assessment of left subclavian artery (LSA) occlusion

Dr. Eric Roselli, who leads the ARTIZEN trial as the Global Principal Investigator and is also the Chief of Adult Cardiac Surgery at Cleveland Clinic, emphasized the complexity of surgeries involving the aortic arch. Given the challenging anatomic location of the left subclavian artery deep within the chest, he highlighted the Arcevo device as a pivotal advancement that may streamline surgical procedures, enhancing safety and speed for patients.

Company Goals and Market Potential

Pat Mackin, the CEO and Chairman of Artivion, expressed enthusiasm regarding the first patient enrolled in the trial, marking a positive progression for the company. He anticipates that successful results from this pivotal trial may open a market opportunity valued at around $80 million in the U.S. as soon as 2029, contingent on obtaining Premarket Approval (PMA) from the FDA for the Arcevo LSA. This approval would significantly enhance the treatment landscape for patients suffering from complex aortic conditions.

The Arcevo™ LSA Hybrid Stent Graft System

The Arcevo LSA device features a self-expanding stent graft specifically designed for the aorta and integrates a stented LSA branch. It melds next-generation technology with a preloaded delivery system that ensures precise deployment during a Frozen Elephant Trunk (FET) procedure. This innovative design eliminates the need for a standard LSA anastomosis while allowing for a more proximal repair, addressing one of the surgical process's most complex areas. Such advancements are expected to significantly reduce circulatory arrest times and minimize complications such as bleeding and nerve injury, ultimately enhancing patient outcomes.

About Artivion, Inc.

Headquartered in the Atlanta suburbs, Artivion, Inc. is dedicated to creating simple yet effective solutions to the challenges faced by cardiac and vascular surgeons grappling with aortic diseases. The company's diverse product portfolio includes aortic stent grafts, surgical sealants, On-X mechanical heart valves, and various implantable cardiac and vascular tissues. With operations extending to over 100 countries worldwide, Artivion aims to bolster the capabilities of health professionals and provide advanced solutions to patients in need.

For more insights on Artivion and its groundbreaking innovations, please visit their official website at www.Artivion.com.