Endologix LLC announced the company’s ChEVAS (Chimney EndoVascular Aneurysm Sealing) System has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration. The ChEVAS System is an investigational endovascular abdominal aortic aneurysm sealing therapy designed to combine the Nellix 3.5 endograft with parallel visceral stents to enable treatment of patients with juxtarenal, pararenal and suprarenal AAA. The FDA Breakthrough Devices Program gives patients more timely access to medical devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Breakthrough Devices receive priority review by FDA, and the program provides opportunities for early interaction with FDA personnel to expedite the review and approval process. ChEVAS is currently being evaluated through the ChEVAS ONE Investigational Device Exemption clinical study that 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.