Endologix receives IDE approval for a pivotal trial for the Nellix Chimney EndoVascular Aneurysm Sealing Protocol
- Endologix, Inc. a developer and marketer of innovative treatments for aortic disorders, 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 Nellix Chimney EndoVascular Aneurysm Sealing System ("ChEVAS") for the endovascular treatment of complex abdominal aortic aneurysms (“AAA”).
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 juxta-renal, pararenal, and suprarenal AAA. The application of endovascular aneurysm sealing (“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.
Comment: Endologix, Inc. announced an agreement naming Boston Scientific Corporation the exclusive distributor for Endologix products in China. The long-term agreement includes distribution rights to Endologix’s current EndoVascular Aneurysm Repair (EVAR) and Endovascular Aneurysm Sealing (EVAS) products, as well as the right of first negotiation for future product offerings by Endologix.
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