Endologix has completed enrolment in the EVAS2 confirmatory clinical study, which will evaluate the Nellix EndoVascular Aneurysm Sealing (EVAS) system.
The company submitted an IDE supplement to the US Food and Drug Administration (FDA) in response to the Covid-19 pandemic and the delay in recruiting patients across many clinical trials.
It includes 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.
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.
Endologix CEO John Onopchenko said: “The completion of enrolment in our EVAS2 study is an exciting milestone for Endologix and for the treatment of abdominal aortic aneurysms.
“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).
In March, the company received the US FDA approval for Endologix Alto Abdominal Stent Graft System. It is designed to expand the endovascular aneurysm repair (EVAR) for treating affected patients.