Artivion has treated the first subject in the multi-centre ARTIZEN pivotal study to assess the Arcevo LSA hybrid stent graft system for individuals with acute and chronic aortic arch pathologies.
ARTIZEN is structured as a non-randomised, prospective trial, enrolling 132 subjects across Europe and the US at up to 30 sites.
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Participants included in the trial have been diagnosed with either aortic dissection or aneurysm involving the aortic arch.
Each subject will be monitored for as long as five years, with primary consideration given to results at the one-year mark.
Combined endpoints for efficacy and safety will assess Arcevo LSA’s effect on incidence of new permanent disabling stroke, new onset permanent paraplegia or paraparesis, unplanned aortic reoperation within the treated segment, left subclavian artery (LSA) occlusion and on minimising all-cause mortality.
The company plans to use findings from this trial to support its future application for premarket approval (PMA) from the US Food and Drug Administration (FDA).
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By GlobalDataArtivion CEO, chairman and president Pat Mackin said: “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.
“We estimate a PMA for Arcevo would open an incremental $80m US market opportunity as soon as 2029.”
Arcevo LSA features a self-expanding stent graft that includes a stented LSA branch.
It comes preassembled on a delivery system designed to ensure precise and controlled placement into both the transected aorta and LSA during a frozen elephant trunk operation.
The stented branch of the device enables surgeons to conduct proximal repairs, with the main connection in Zone 2.
This approach is designed to decrease the duration of circulatory arrest, reduce blood loss and nerve complications, and enhance overall patient outcomes in challenging aortic arch repairs.
The company specialises in cardiac and vascular surgery, with an emphasis on aortic conditions.
