Enrollment Completed in ELEVATE IDE Study of Endologix's Alto EVAR System
February 5, 2018—Endologix announced the completion of enrollment in the ELEVATE investigational device exemption (IDE) clinical study. The objective of the 75-patient study is to evaluate the safety and effectiveness of the company's Alto abdominal stent graft system for endovascular aneurysm repair (EVAR) of infrarenal abdominal aortic aneurysms (AAAs).
The company plans to file regulatory submissions in the third quarter of 2018 and anticipates potential approval of the Alto device in both the United States and European markets in 2019.
Alto is a new-generation–polymer EVAR system that expands patient applicability by moving the polymer sealing ring near the proximal edge of the graft. Alto is an investigational device not currently approved in any market, and its safety and effectiveness have not been established, advised Endologix.
In the company's announcement, the ELEVATE Principal Investigator Sean Lyden, MD, commented, "We are pleased to complete enrollment of the ELEVATE IDE trial and look forward to evaluating the clinical results later this year. The Alto device incorporates several design enhancements that are intended to simplify the procedure and enable the system to treat a wider range of AAA anatomies than Ovation iX." Dr. Lyden is Chairman of the Department of Vascular Surgery at Cleveland Clinic in Cleveland, Ohio.