Endologix has completed enrolment in the EVAS2 confirmatory clinical study, which will evaluate the Nellix EndoVascular Aneurysm Sealing (EVAS) system.
It includes a revised Statistical Analysis Plan that is consistent with the recently published F DA Guidance document, Conduct of Clinical Trials of Medical Products during Covid-19 Pandemic.
The company proposed minimum sample size of 95 patients in its submission with no change to the defined endpoints of the study.
While the power of the two-year effectiveness endpoint has been reduced to 87.4% from 93.8%, the power of the safety endpoint is maintained at 99.9%.
The statistical power of both endpoints remains well above the 80% benchmark normally used in this therapeutic area, the company noted.
“We are very grateful for the ongoing collaboration and partnership with our investigators who continue to work side-by-side with us to make this trial successful.”
The company is currently in the process of preparing a premarket approval (PMA) submission. It plans to submit the PMA shortly after the first 95 patients in the trial reach one-year follow-up in March next year.
Endologix develops and manufactures minimally invasive treatments for aortic disorders, including abdominal aortic aneurysms (AAA).