Endologix Wins FDA Green Light for Aneurysm Sealing System

[Image from Endologix]

Endologix today announced that the FDA has granted breakthrough device designation for its Chimney Endovascular Aneurysm Sealing System (Chevas).

Endologix, based in Irvine, Calif., Designed its Chevas System as an abdominal aortic aneurysm (AAA) endovascular sealing therapy that combines the Nellix 3.5 stent with parallel visceral stents to treat patients with ‘a juxtarenal, pararenal and suprarenal AAA, according to a press release.

The company is currently evaluating the Chevas system as part of the Chevas One Experimental Device Exemption (IDE) clinical study, which is expected to enroll approximately 120 patients at 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 principal national investigators of the study. .

Lead study participant Dr James McKinsey said in the statement that Endologix engineered aneurysm sac technology in the Chevas system to reduce endoleaks – including gutter endoleaks – that are reported after treatment. endovascular complex aneurysms. McKinsey will present his first experience with Chevas at the Eastern Vascular Society’s annual meeting on September 26.

“The Chevas System represents an important therapy that provides ‘out of the box’ treatment to an underserved patient population with complex abdominal aortic aneurysms,” said Dr. Matt Thompson, CMO of Endologix. “We are delighted that the FDA has designated Chevas as a breakthrough device, as it will facilitate our ability to develop this technology and make it available to patients on an accelerated basis. The Chevas System joins the PQ Bypass Detour System as two breakthrough devices designated by the FDA in our clinical investigation programs, reflecting our aspiration to provide innovative and disruptive technologies to fill clinically relevant therapeutic gaps.

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