Endologix ChEVAS System Receives FDA Breakthrough Device Designation

July 19, 2021—Endologix LLC announced that the company’s chimney endovascular aneurysm sealing (ChEVAS) system, has been granted a Breakthrough Device designation from the FDA.

The ChEVAS system is an investigational endovascular abdominal aortic aneurysm (AAA) sealing therapy designed to combine the company’s Nellix 3.5 endograft with parallel visceral stents to enable treatment of patients with juxtarenal, pararenal, and suprarenal AAA.

According to the company, ChEVAS is currently being evaluated through the ChEVAS ONE investigational device exemption (IDE) clinical study. ChEVAS ONE is approved to enroll approximately 120 patients at up to 50 clinical sites worldwide. The national Principal Investigators of the ChEVAS ONE study are Francis Caputo, MD; William Jordan, MD; Joseph Lombardi, MD; and William Quinones-Baldrich, MD.

James McKinsey, MD, the leading enroller in the ChEVAS ONE IDE study, will present his initial experience with ChEVAS on September 26 at the Eastern Vascular Society Annual Meeting in Charleston, South Carolina.

“The aneurysm sac sealing technology featured in the ChEVAS system is designed to reduce endoleaks, including gutter endoleaks, that are reported after endovascular treatment of complex aneurysms,” commented Dr. McKinsey, MD, in the Endologix press release. “Our initial clinical results of this therapy have been promising in a challenging group of patients.”