Endologix has been granted CE mark approval for its Nellix endovascular aneurysm sealing system, with refined Instructions for Use (IFU). Nellix is being studied in the USA under a US Food and Drug Administration (FDA) Investigational Device Exemption (IDE).
Nellix originally received CE mark last year. The first procedures with the system were performed by associate professor Andrew Holden and Andrew Hill at Auckland City Hospital, Auckland, New Zealand. Endologix says that it is “the first and only EVAS product” and was “developed to reduce all types of endoleaks and improve long-term patient outcomes”. The system is intended to enhance ease of use and offers physicians more sizes to treat more patients with AAA.
Following a review of supporting clinical data, the company’s notified body, together with an independent clinical reviewer, determined that Nellix—with this refined IFU—meets the applicable safety and clinical performance requirements. As a result of these evaluations, the notified body granted a CE mark for Nellix with the refined IFU.
“We are very pleased with the clinical outcomes generated by the Nellix endovascular aneurysm sealing system utilising the refined IFU,” comments John McDermott, Endologix’s chief executive officer. “The Nellix CE mark with the refined IFU provides patients and physicians in Europe with continued access to…complete aneurysm sealing, including low rates of endoleaks and all-cause mortality.”