The EVAS2 IDE Multicenter Safety and Effectiveness Confirmatory Study (EVAS2) 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 one-year follow-up data required for the Pre-market Approval application.
The Nellix EVAS system is an endovascular abdominal aortic aneurysm (AAA) therapy designed to seal the entire aneurysm. Nellix is the first and only EVAS product developed as an alternative treatment approach to traditional EVAR devices.
John McDermott, CEO for Endologix, said, "We are pleased to receive IDE approval from the FDA to begin this confirmatory study and look forward to collaborating with the investigators to achieve the goal of commencing enrollment by the end of this year. Based on the anticipated enrollment timeline, one-year follow up period, and regulatory review process, we continue to estimate PMA approval in 2020."
Endologix Inc. develops and manufactures minimally invasive treatments for aortic disorders. The company's focus is endovascular stent grafts for the treatment of abdominal aortic aneurysms. AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 80 percent, making it a leading cause of death in the United States.
The Nellix EndoVascular Aneurysm Sealing System has obtained CE Mark in the European Union and is only approved as an investigational device in the United States.