“The completion of enrollment in our EVAS2 study is an exciting milestone for Endologix and for the treatment of abdominal aortic aneurysms,” commented John Onopchenko, CEO of Endologix. “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.”
In response to the current COVID-19 pandemic and the delay in recruiting patients across many clinical trials, Endologix submitted an IDE supplement to the U.S. Food and Drug Administration (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.
The submission proposed a minimum sample size of 95 patients, with no alteration to the defined end points of the study. The power of the two-year effectiveness endpoint has been reduced to 87.4 percent from 93.8 percent, and the power of the safety endpoint remains 99.9 percent. The statistical power of both end points remains well above the 80 percent benchmark typically used in this therapeutic area.
The company is currently in the process of preparing a PMA submission, which it plans to submit shortly after the first 95 patients in the trial reach one-year follow-up in March 2021.
Earlier this year, Endologix received FDA approval for the Alto Abdominal Stent Graft System (Alto).
The company received approval based on its regulatory submission that includes the ELEVATE Investigational Device Exemption (IDE) clinical study. Pursuant to the terms of approval, the first 100 patients after commercial launch will be included in a post approval imaging study to determine consistency in device selection between Endologix’s internal imaging services and those of the implanting physicians.
“We are thrilled to receive approval for the Alto system,” commented Matt Thompson, chief medical officer of Endologix. “We have worked collaboratively with the FDA throughout the Alto premarket approval (PMA) process, and we will be carefully monitoring intra-procedural events as Alto ramps to full commercialization. We anticipate observing improved short-term outcomes relative to the Ovation iX Abdominal Stent Graft System (Ovation iX) as a result of the design and manufacturing changes incorporated into Alto. However, as we expect Ovation iX to remain commercially available for a period of time subsequent to the Alto launch, we will also be updating our previous 2018 safety communication as it relates to the Ovation iX system.”