European CE Mark Reinstated for Endologix's Nellix EVAS System
June 6, 2019—Endologix, Inc. announced that CE Mark certification for the company's Nellix endovascular aneurysm sealing (EVAS) system has been reinstated by GMED, the European Union Notified Body for the device, after an assessment of clinical evidence. The Nellix system is intended for the treatment of abdominal aortic aneurysms.
In January 2019, the company announced that the CE Mark certification had been suspended in response to a voluntary recall and Field Safety Notification.
As previously disclosed, the Nellix system will be made available for use at approved centers in a postmarket clinical investigational setting outside the United States. Within the United States, the Nellix system remains an investigational device as part of the EVAS2 study.
Matt Thompson, MD, Chief Medical Officer of Endologix, stated in the announcement, “We continue to believe that the Nellix system has the potential to transform the treatment of patients with infrarenal abdominal aortic aneurysms. This therapy continues to generate positive results when used in patients that conform to the anatomical indications for use. We are delighted that the available data supports the reinstatement of our CE Mark, and we look forward to utilizing this technology to improve the patient experience and drive better outcomes.”