Endologix Receives IDE Approval for the EVAS2 Confirmatory Clinical Study
October 6, 2017—Endologix, Inc. announced that it has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence a confirmatory clinical study to evaluate the safety and effectiveness of the company's Nellix endovascular aneurysm sealing (EVAS) system for the treatment of infrarenal abdominal aortic aneurysms.
According to Endologix, the EVAS2 IDE multicenter safety and effectiveness confirmatory study will prospectively evaluate the refined indications for use and the Nellix Gen2 EVAS system. The study is approved to enroll up to 90 primary patients, with 1-year follow-up data required for the premarket approval application.
Nellix, which is designed to seal the entire aneurysm, was developed as an alternative treatment approach to traditional endovascular aneurysm repair devices. The company continues to estimate that the device will receive FDA premarket approval in 2020.