Endologix Study for Aortic Aneurysms Device

FDA has given Endologix the green light to begin a pivotal study to evaluate the safety and effectiveness of its Nellix Chimney EndoVascular Aneurysm Sealing System and its use for the endovascular treatment of complex abdominal aortic aneurysms (AAA). The device combines the company’s Nellix 3.5 endograft with parallel visceral stents to enable treatment of patients with juxta-renal, para-renal, and suprarenal AAA. The study will recruit 120 patients with complex AAA in up to 50 centers, both in the U.S. and internationally.

AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once an AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 80%, making it a leading cause of death in the U.S., the company says.