Endologix Chevas
[Image from Endologix]

Endologix announced today that the FDA granted breakthrough device designation for its Chimney endovascular aneurysm sealing system (Chevas).

Irvine, Calif.-based Endologix designed its Chevas system as an investigational endovascular abdominal aortic aneurysm (AAA) sealing therapy that combines the Nellix 3.5 endograft with parallel visceral stents to treat patients with juxtarenal, pararenal and suprarenal AAA, according to a news release.

The company is currently evaluating the Chevas system through the Chevas One investigational device exemption (IDE) clinical study, set to enroll approximately 120 patients across up to 50 clinical sites around the world.

Dr. Francis Caputo (Cleveland Clinic Foundation), Dr. William Jordan (Emory University School of Medicine), Dr. Joseph Lombardi (Cooper University Health Care) and Dr. William Quinones-Baldrich (UCLA) are the national principal investigators for the study.

The study’s leading enrolled, Dr. James McKinsey, said in the release that Endologix designed aneurysm sac technology in the Chevas system to reduce endoleaks — including gutter endoleaks — that are reported after endovascular treatment of complex aneurysms. McKinsey will present his initial experience with Chevas at the Eastern Vascular Society Annual Meeting on Sept. 26.

“The Chevas system represents an important therapy that provides an ‘off-the shelf’ treatment to an underserved patient population who have complex abdominal aortic aneurysms,” Endologix CMO Dr. Matt Thompson said. “We are delighted that the FDA has designated Chevas as a breakthrough device, as this will facilitate our ability to develop this technology and make it available to patients in an expedited fashion. The Chevas System joins the PQ Bypass Detour system as the two FDA-designated breakthrough devices in our clinical investigational programs, which is reflective of our aspiration to provide innovative and disruptive technologies to address clinically relevant therapeutic gaps.”