IRVINE, Calif., April 28, 2016 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today the first data presentation from the ASCEND Registry (Aneurysm Study for Complex AAA: Evaluation of Nellix Durability), a physician-initiated registry of the Nellix® EndoVascular Aneurysm Sealing System ("Nellix EVAS System") used with aortic branch stent grafts for the treatment of patients with complex abdominal aortic aneurysms (“AAAs”). Professor Matthew Thompson, MD, Professor of Vascular Surgery, St. Georges Vascular Institute, London, and one of the principal investigators of the ASCEND Registry, presented the results at the 38th Annual Charing Cross Symposium being held April 26-29 in London, UK. The Nellix EVAS System is approved for investigational use only in the U.S.
The presentation by Dr. Thompson includes one-year outcomes from the first 154 patients enrolled in the ASCEND Registry. Key highlights of the presentation include:
- Patients successfully treated with single, double, triple and quadruple branches
- Target vessel patency of 98-100%
- 1% serious renal complications at 30 days
- 0% persistent endoleaks
- 94% aneurysm-related and 90% overall survival at 12 months follow up
Dr. 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.”
John McDermott, Chairman and Chief Executive Officer of Endologix, said, “The initial data from the ASCEND Registry affirms our confidence in Nellix’s ability to safely treat a wide range of patients. More than one-third of AAA patients have complex anatomy and Nellix has the potential to offer these patients an endovascular solution. We’d like to thank our physician collaborators for their clinical leadership and look forward to continuing our development and clinical activities to bring this important new solution to patients suffering from complex AAA disease.”
The ASCEND Registry will enroll 200 patients with complex AAAs at up to 10 international centers. The complex anatomies include juxta-renal (aneurysm extends up to renal arteries) and para-renal (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 is a new generation of AAA therapy designed to seal the entire abdominal aortic aneurysm sac. It is the first and only EVAS product and was developed to reduce all types of endoleaks and improve long-term patient outcomes. The recently announced second next-generation Nellix EVAS System incorporates design improvements to enhance ease of use and offers physicians more sizes to treat more patients with AAA. Nellix is an investigational device in the United States.
About Endologix, Inc.
Endologix, Inc. develops and manufactures minimally invasive treatments for aortic disorders. The Company's focus is endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once 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. Additional information can be found on Endologix's website at www.endologix.com.
Forward-Looking Statements
This communication includes statements that may be “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to the clinical and commercial potential, and U.S. regulatory approval, of the Nellix EVAS System, the ability of the Nellix EVAS System to treat a broader range of patients and anatomies, the potential of the Nellix EVAS System to become the leading therapy for the treatment of AAA and the broad applicability of the Nellix EVAS System, Chairmanthe accuracy of which are necessarily subject to risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix. Many factors may cause actual results to differ materially from anticipated results, including unanticipated clinical outcomes and delays in the regulatory approval process. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Endologix undertakes no obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Endologix's Annual Report on Form 10-K for the year ended December 31, 2015, and Endologix's subsequent filings with the Securities and Exchange Commission, for more detailed information regarding these risks and other factors that may cause actual results to differ materially from those expressed or implied.