Irvine, California-based Endologix designed the AFX2 system with unique sealing technology that preserves native bifurcation to provide durable outcomes and personalized repair for AAA patients.
“CE Mark certification under the new [EU MDR] requirements is a high-bar and we are proud of this significant company achievement,” Elisa Hebb, Endologix EVP of medical, clinical, regulatory affairs and quality, said in a news release. “Meeting the rigor of the new framework is an important milestone for our AFX2 System.”
Endologix introduced the currently marketed AFX2 system in 2016 and had its comparative performance studied in the Leopard randomized clinical trail that evaluated AFX2 and its AFX predecessor device to other commercially available endografts.
Five-year results from the study will be made available this year, while four-year results demonstrated that freedom from aneurysm-related complications was similar between the AFX and AFX2 cohort and comparator endografts.
“We believe AFX2 offers an innovative solution for AAA and continues to play a significant role in clinical practice due to its differentiated design features and the compendium of clinical evidence,” Endologix President and CEO Matt Thompson said. “We are committed to investing in clinical research to evaluate the long-term outcomes of our products. Evidence to date supports the comparative effectiveness of AFX2 in the treatment of patients with abdominal aneurysms.”