Endologix AFX 2 Endovascular AAA System Receives CE Mark Certification Under New EU-MDR

August 4, 2022—Endologix LLC announced that is has received CE Mark certification under the new European Union Medical Devices Regulation (EU-MDR, 2017/745) for the company’s AFX2 endovascular aortic abdominal aneurysm (AAA) system, which integrates anatomical fixation into aortic endografts with an advanced delivery system to treat patients with AAA.

According to the company, the EU-MDR is a regulation for medical devices applied by the European Commission that was released in 2017 and effective as of May 26, 2021. It replaces the Medical Devices Directive. 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.

Elisa Hebb, Executive Vice President of Medical, Clinical, Regulatory Affairs, and Quality at Endologix, commented in the company’s press release, “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.”

Matt Thompson, President, and CEO of Endologix, added, “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. 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.”

Endologix advised that the currently marketed AFX2 system was introduced in 2016. The device’s comparative performance is being evaluated 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 5-year results of the LEOPARD study will be available later this year. The 4-year results demonstrated that freedom from aneurysm-related complications was similar between the AFX and AFX2 cohort and comparator endografts, advised the company.