IRVINE, Calif., April 27, 2016 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today the presentation of positive clinical data for the Nellix® EndoVascular Aneurysm Sealing System ("Nellix EVAS System") at the 38th Annual Charing Cross Symposium being held April 26-29 in London, UK. This includes updated data from the Nellix EVAS-FORWARD – Global Registry and a data presentation from Jean-Paul De Vries, MD, PhD, Head of Department of Vascular Surgery at St. Antonius Hospital (Nieuwegein, Netherlands) entitled “Endovascular sealing of common iliac artery aneurysms - multi centre experience”. The Nellix EVAS System is approved for investigational use only in the U.S.
Global Registry data includes a total of 300 patients with a mean follow-up of 20 months. The key highlights from the Global Registry data included:
- 37% of patients treated had complex abdominal aortic aneurysms
- Freedom from endoleaks of 98%
- Secondary interventions in 6.5% of patients treated on-label
- 98% aneurysm-related and 93% overall survival
The study results presented by Dr. De Vries included 72 patients with AAA and iliac artery aneurysms treated with the Nellix EVAS System. Forty percent of patients had iliac artery aneurysm diameters beyond indications for use in traditional EVAR devices. The patients were enrolled at 9 centers and had a mean follow-up of 13 months.
The highlights from the data include:
- 100% technical success
- Mean common iliac artery diameters of 35mm (right CIA) and 29mm (left CIA)
- 108 minute average procedure time
- Secondary intervention rate of 5.6%
Dr. De Vries commented, “Up to one-third of AAA patients also have some form of iliac artery aneurysm, which can involve more complex and expensive procedures including embolization and iliac branch devices. The results from our study demonstrate that the Nellix device can safely and effectively treat these patients with a straightforward, faster and cost-effective procedure.”
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 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.
John McDermott, Chairman and Chief Executive Officer of Endologix, said, “We are encouraged by the continued positive clinical data on Nellix from the Global Registry and other physician initiated studies presented at Charing Cross. The data from the registry and Dr. De Vries’ study demonstrate the broad range of anatomies that can be addressed with the Nellix aneurysm sealing technology. We have a significant presence at the Charing Cross meeting, highlighting our Nellix, AFX and Ovation platforms, which position Endologix as the only company with a broad range of AAA products that allow physicians to select the best device for each patient.”
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.
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, the 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.
ENDOLOGIX CONTACT: Endologix, Inc. John McDermott, CEO Vaseem Mahboob, CFO (949) 595-7200 www.endologix.com INVESTOR CONTACTS: The Ruth Group Nick Laudico (646) 536-7030 Zack Kubow (646) 536-7020