Endologix Takes a Step Forward with Nellix IDE

Endologix has received investigational device exemption (IDE) approval from FDA for a new pivotal study to evaluate the safety and effectiveness of the Nellix Chimney Endovascular Aneurysm Sealing System for the endovascular treatment of complex abdominal aortic aneurysms (AAA). The 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, para-renal, and suprarenal AAA. The application of endovascular aneurysm sealing for patients with complex aneurysms will offer innovative new technology to a group of patients that are underserved by the current standard of care, the Irvine, CA-based company said. The pivotal study will recruit 120 patients with complex AAA in up to 50 centers, both in the United States and outside the United States. Enrollment is expected to begin early next year. "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," said CEO John Onopchenko. Boston Scientific to Distribute Endologix Products in China Also on Friday, Endologix disclosed an agreement naming Boston Scientific the exclusive distributor of Endologix products in China beginning with AFX2, but eventually including all of the products in the company's EVAR and EVAS portfolio. China represents a roughly 200 million...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Regulatory and Compliance Source Type: news