Endologix announces CE mark for Nellix EVAS system

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Endologix has received CE mark for the next-generation Nellix Endovascular Aneurysm Sealing (EVAS) system. The first procedures with the system were performed by associate professor Andrew Holden and Andrew Hill at Auckland City Hospital, Auckland, New Zealand.

Holden commented, “The new Nellix system includes more sizes to treat a wider range of abdominal aortic aneurysm (AAA) patients, plus gives us the ability to precisely treat patients with complex iliac anatomy. In our hospital, patients with short or aneurysmal iliac arteries represent 30% of the diagnosed AAAs. With the new Nellix system, we now have a solution for these challenging anatomies and look forward to treating more patients. The first procedures with the new Nellix system have been a success and post-procedure imaging confirmed the device was accurately deployed and the aneurysm was properly sealed.”

The EVAS system is a new generation of AAA therapy designed to seal the entire abdominal aortic aneurysm sac. 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 incorporates design improvements to enhance ease of use and offers physicians more sizes to treat more patients with AAA. Nellix is an investigational device in the USA.

John McDermott, chief executive officer, said, “The new Nellix system was developed based upon physician feedback over the past two years. It incorporates several enhancements that simplify the procedure and expand the available sizes to treat a wider range of AAA patients and anatomies.”

McDermott continued, “The new Nellix system will be gradually introduced in Europe and other markets over the next several months, and is the same device we plan to launch in the USA following FDA approval. We recently submitted our final postmarket approval (PMA) modules to the FDA and remain on schedule for potential PMA approval at the end of 2016 or early 2017.”