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August 7, 2019
Endologix Receives IDE Approval for the Nellix Chimney EVAS System
August 8, 2019—Endologix, Inc. announced that it has received investigational device exemption (IDE) approval from the FDA to commence a new pivotal study to evaluate the safety and effectiveness of the company's Nellix chimney endovascular aneurysm sealing (ChEVAS) system for the endovascular treatment of complex abdominal aortic aneurysms (AAAs).
According to Endologix, the ChEVAS system is an endovascular AAA therapy designed to combine the Nellix 3.5 endograft with parallel visceral stents to enable the treatment of patients with juxtarenal, pararenal, and suprarenal AAAs. The study will recruit 120 patients with complex AAAs at up to 50 centers in the United States and internationally.
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