Endologix to Seek FDA Approval of Nellix EVAS System With Confirmatory Study
May 17, 2017—Endologix, Inc. announced it will seek US Food and Drug Administration (FDA) approval for its Nellix endovascular aneurysm sealing (EVAS) system by conducting a confirmatory clinical study using the previously updated instructions for use and Gen2 device design.
The company will collaborate with the FDA on the development of the clinical study protocol, with patient enrollment anticipated to begin in the fourth quarter of 2017. According to the company, premarket approval is estimated to occur in 2020.
Endologix also noted that clinical outcomes with the Nellix EVAS system will be reported at two upcoming medical meetings, Critical Issues in Aortic Endografting in Nuremberg, Germany, on May 19–20, 2017, and the Vascular Annual Meeting in San Diego, California, on May 31–June 3, 2017.
The Nellix EVAS Gen2 system is currently available for commercial use in Europe and other international markets.