ASCEND Data Support Endologix Nellix EVAS System to Treat Juxtarenal and Pararenal AAAs

April 28, 2016—Endologix, Inc. announced the first data presentation from the ASCEND Registry (Aneurysm Study for Complex Abdominal Aortic Aneurysm [AAA]: Evaluation of Nellix Durability), a physician-initiated registry of the Nellix EndoVascular Aneurysm Sealing (EVAS) system used with aortic branch stent grafts for the treatment of patients with complex AAAs. In November, the company announced the start of the registry, which is being conducted outside the United States.

Prof. Matthew Thompson, MD, presented the results at the Charing Cross Symposium in London, United Kingdom. Prof. Thompson, one of the Principal Investigators of the ASCEND Registry, is Professor of Vascular Surgery at St. Georges Vascular Institute in London, United Kingdom.

The presentation included 1-year outcomes from the first 154 patients enrolled in the ASCEND Registry who had single, double, triple, or quadruple branches that were successfully treated. Results included target vessel patency (98%–100%), serious renal complications at 30 days (1%), persistent endoleaks (0%), aneurysm-related survival (94%), and overall survival at 12-month follow-up (90%).

In the Endologix press release, Prof. Thompson commented, “As anticipated, early data from the ASCEND Registry confirms Nellix’s ability to effectively treat AAA patients with a wide range of complex anatomies. The initial results demonstrate a low endoleak rate, positive aortic branch patency and very good survival. Given the limited treatment options for complex AAAs, we are pleased that Nellix is proving to be a safe, off-the-shelf solution for this patient population.”

The ASCEND Registry will enroll 200 patients with complex AAAs at up to 10 international centers. The complex anatomies include juxtarenal (aneurysm extends up to renal arteries) and pararenal (aneurysm includes renal arteries) AAAs. It is an open-label, single-arm, observational real-world registry with no prospective screening. The endpoints of the ASCEND Registry include overall and aneurysm-related mortality, major adverse events, endoleak and secondary intervention rates, Nellix and aortic branch stent graft patency, renal function, and durability.

The Nellix EVAS system, which was developed to mitigate all types of endoleaks, and improve stability and long-term patient outcomes, is designed to seal the entire aneurysm sac. The device received European CE Mark approval in 2013 for the treatment of patients with infrarenal AAAs. The recently announced next-generation Nellix EVAS System incorporates design improvements to enhance the ease of use and offers physicians varying sizes to treat more patients with AAA. Nellix is an investigational device in the United States.