Artivion, Inc.

Artivion is a specialized cardiovascular medical device company focused exclusively on aortic and cardiac surgery solutions. The company manufactures and markets a comprehensive portfolio of devices for treating aortic diseases, aortic dissections, and cardiac valve disorders. Product lines include mechanical and biological heart valves (ON-X Aortic and Mitral Valves, CRYOVALVE allografts), aortic arch solutions (AMDS Hybrid Prosthesis, E-VITA OPEN NEO, NEXUS stent graft systems), thoracoabdominal and abdominal aortic stent grafts (E-TEGRA, E-LIAC, E-NSIDE TAAA), peripheral aortic devices, and ancillary surgical solutions including BIOGLUE surgical adhesive and decellularized pericardium (PHOTOFIX). Artivion recently acquired Ascyrus Medical in 2020, expanding its aortic arch offerings. The AMDS Hybrid Prosthesis, developed for acute DeBakey Type I aortic dissections, received FDA Humanitarian Device Exemption (HDE) in December 2024 and is supported by the PERSEVERE pivotal clinical trial. Products are regulated through FDA 510(k) clearances and PMA pathways, with multiple investigational device exemptions (IDEs) active. The company collaborates with cardiac and vascular surgeons worldwide and supports clinical evidence generation through real-world post-market studies and pivotal trials. Artivion serves hospitals, surgical centers, and cardiac/vascular surgery programs globally, with particular emphasis on advanced aortic interventions and valve replacement technologies.