Endologix's Next-Generation Nellix EVAS System Approved in Europe

April 11, 2016—Endologix, Inc. announced that the company’s next-generation Nellix endovascular aneurysm sealing (EVAS) received European CE Mark approval system for the treatment of aortic abdominal aneurysm (AAA). The new Nellix system will gradually be introduced in Europe and other markets over the next several months. The first procedures with the new Nellix EVAS system were performed by Andrew Holden, MBChB, and Andrew Hill, MBChB, at Auckland City Hospital in Auckland, New Zealand.

According to the company, the Nellix EVAS system is designed to seal the entire AAA sac. The EVAS device was developed to reduce all types of endoleaks and improve long-term patient outcomes. This next-generation Nellix EVAS system incorporates design improvements to enhance ease of use and offers physicians more sizes to treat more patients with AAA.

In Endologix press release, Dr. Holden commented, “The new Nellix system includes more sizes to treat a wider range of 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 postprocedure imaging confirmed the device was accurately deployed and the aneurysm was properly sealed.”

Nellix is an investigational device in the United States. Endologix recently submitted the final postmarket approval modules to the US Food and Drug Administration and remain on schedule for potential approval at the end of 2016 or early 2017, advised the company.