May 11, 2020
Endologix Completes Enrollment in the EVAS2 Confirmatory Clinical Study
May 11, 2020—Endologix Inc. announced that it has completed enrollment in the EVAS2 confirmatory clinical study to evaluate the Nellix endovascular aneurysm sealing (EVAS) system.
In response to the current COVID-19 pandemic and the delay in recruiting patients across many clinical trials, Endologix submitted an investigational device exemption (IDE) supplement to the FDA with a revised Statistical Analysis Plan that is consistent with the recently published FDA guidance document, Conduct of Clinical Trials of Medical Products during COVID-19 pandemic.
According to the company, the submission proposed a minimum sample size of 95 patients, with no alteration to the defined endpoints of the study. The power of the 2-year effectiveness endpoint has been reduced to 87.4% from 93.8%, and the power of the safety endpoint remains 99.9%. The statistical power of both endpoints remains well above the 80% benchmark typically used in this therapeutic area.
Endologix advised it is currently in the process of preparing a premarket approval submission for EVAS system, which it plans to submit shortly after the first 95 patients in the trial reach 1-year follow-up in March 2021.