Endologix LLC, a privately held global medical device company dedicated to improving patients’ lives with innovative interventional treatments for vascular disease, announced that is has received CE Mark Certification under the new EU Medical Devices Regulation [EU-MDR [(Regulation (EU) 2017/745)] for its AFX2 Endovascular AAA System.
The EU-MDR is a regulation for medical devices applied by the European Commission, released in 2017 and effective as of May 26, 2021. It replaces the Medical Devices Directive (MDD). The intent of the EU MDR is to ensure a high standard of safety and quality for medical devices that are produced in, or supplied to, member countries of the European Union.
“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,” said Elisa Hebb, Endologix’s EVP of Medical, Clinical, Regulatory Affairs and Quality.
“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,” said 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 currently marketed AFX2 System was introduced in 2016 and its comparative performance is studied in the LEOPARD Randomized Controlled Trial. The study was designed to directly compare AFX2 and the predecessor AFX device, to other commercially available endografts. The five-year results of this study will be available later this year, while the four-year results demonstrated that freedom from aneurysm related complications was similar between the AFX and AFX2 cohort and comparator endografts.