Endologix has received Investigational Device Exemption (IDE) approval from the FDA to commence a new pivotal study to evaluate the safety and effectiveness of the its chimney endovascular aneurysm sealing system (ChEVAS) for the endovascular treatment of complex abdominal aortic aneurysms.

A press release reports that the ChEVAS system is an endovascular abdominal aortic aneurysm therapy designed to combine the Nellix 3.5 endograft with parallel visceral stents to enable treatment of patients with juxtarenal, pararenal, and suprarenal aneurysms. It adds that the application of EVAS for patients with complex aneurysms will offer innovative new technology to a group of patients that are underserved by the current standard of care.

John Onopchenko, Chief Executive Officer for Endologix, comments: “We are pleased to receive IDE approval from the FDA to begin this study, which will recruit 120 patients with complex AAA in up to 50 centres, both in the USA and internationally. This approval marks another step forward on our path to re-establishing durable, predictable growth through a continued focus on execution and evidence-driven differentiation.”