Sam Brusco, Associate Editor08.08.22
Endologix has earned CE mark certification for its AFX2 endovascular AAA system under the new European Medical Devices Regulation (EU-MDR).
“CE Mark certification under the new requirements is a high-bar and we are proud of this significant company achievement. Meeting the rigor of the new framework is an important milestone for our AFX2 System,” Elisa Hebb, Endologix’s EVP of Medical, Clinical, Regulatory Affairs and Quality told the press.
“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,” added Matt Thompson, president and CEO of Endologix, “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.”
The AFX2 system was introduced in 2016, with comparative performance studied in the LEOPARD trial. The study compared AFX2 and its AFX predecessor to commercially available endografts.
5-year results will be released later this year. 4-year results showed freedom from aneurysm related complications was similar between AFX and AFX2 cohort and comparator endografts.
“CE Mark certification under the new requirements is a high-bar and we are proud of this significant company achievement. Meeting the rigor of the new framework is an important milestone for our AFX2 System,” Elisa Hebb, Endologix’s EVP of Medical, Clinical, Regulatory Affairs and Quality told the press.
“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,” added Matt Thompson, president and CEO of Endologix, “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.”
The AFX2 system was introduced in 2016, with comparative performance studied in the LEOPARD trial. The study compared AFX2 and its AFX predecessor to commercially available endografts.
5-year results will be released later this year. 4-year results showed freedom from aneurysm related complications was similar between AFX and AFX2 cohort and comparator endografts.