Endologix today announced the company’s ChEVAS (chimney endovascular aneurysm sealing) system has been granted a Breakthrough Device designation from the US Food and Drug Administration (FDA). The ChEVAS system is an investigational endovascular abdominal aortic aneurysm (AAA) 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.
ChEVAS is currently being evaluated through the ChEVAS ONE investigational device exemption (IDE) clinical study that is approved to enrol approximately 120 patients at up to 50 clinical sites worldwide. The national principal investigators of the ChEVAS ONE study are Francis Caputo (Cleveland Clinic Foundation, Cleveland, USA); William Jordan (Emory University School of Medicine, Atlanta, USA); Joseph Lombardi (Cooper University Health Care, Camden, USA); and William Quinones-Baldrich (UCLA, Los Angeles, USA).
“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,” said James McKinsey (The Icahn School of Medicine at Mount Sinai, New York, USA), the leading enroller in the ChEVAS ONE IDE study. “Our initial clinical results of this therapy have been promising in a challenging group of patients.”
McKinsey will present his initial experience with ChEVAS at the Eastern Vascular Society Annual Meeting (23–26 September, Charleston, USA).