IRVINE, Calif., Nov. 20, 2014 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today the presentation of initial clinical data from the Company's EVAS FORWARD – Global Registry, a post-market study that prospectively enrolled patients with abdominal aortic aneurysms ("AAAs") who were treated with the Nellix® EndoVascular Aneurysm Sealing System ("Nellix EVAS System"). The study enrolled 300 patients under a protocol having no anatomical restrictions, and represented a broad range of AAA anatomies. The study includes core lab assessment of CT scans and independent physician adjudication of outcomes. The Nellix EVAS System is approved for investigational use only in the US.
From October 2013 to September 2014, clinical investigators enrolled 300 patients treated with the Nellix EVAS System at centers in Europe and New Zealand. Patients enrolled in the EVAS FORWARD – Global Registry will be followed for five years, with primary endpoints evaluating safety and effectiveness of the Nellix EVAS System at 12 months post procedure.
Andrew Holden, MD, Associate Professor of Radiology at Auckland City Hospital (Auckland, New Zealand) and one of the principal investigators of the EVAS FORWARD – Global Registry, presented the results at the VEITH symposium. At this interim analysis, mean patient follow-up is 165 days; maximum is one year. Key highlights from the data included:
- Patients were enrolled with a broad range of aortic anatomies and a median AAA sac diameter of 6cm. 34% of patients enrolled in the Registry were considered to be anatomically complex and difficult to treat with available EVAR devices.
- Favorable median fluoroscopy times and procedure times were observed across the entire study group (11 and 98 minutes, respectively).
- In the early post-operative period, safety results are very positive with no device-related mortality.
- Follow-up to one year indicated an overall endoleak rate of 1.1%, representing the lowest overall endoleak rate ever reported for any commercially available endovascular device treating AAA.
- Overall device-related reintervention was 1.1%.
Dr. Holden commented, "The early results from the Nellix EVAS FORWARD – Global Registry are promising. The data shows the lowest overall level of endoleaks reported for any endovascular device used to treat AAA and a correspondingly low reintervention rate. It is important to realize that these results were achieved in a very broad range of AAA anatomies including many patients that were not be candidates for EVAR."
The Nellix EVAS System is a new generation of AAA therapy designed to seal the entire aneurysm sac. The Nellix EVAS System is the first and only EVAS product and was developed to mitigate all types of endoleak and reduce reinterventions. Endologix received CE Mark for the Nellix EVAS System in the first quarter of 2013. Additional interim data are expected to be presented over the course of the five-year follow-up period. The next data presentation from the registry is anticipated at the Charing Cross International Symposium, which is being held from April 28 to May 1, 2015, in London.
John McDermott, Chairman and Chief Executive Officer of Endologix, said, "The initial results from the EVAS FORWARD – Global Registry are characterized by a real-world patient population with AAA for whom physicians are seeking a durable treatment option. We applaud the investigators and participating centers for their diligence in completing enrollment in less than one year, and are encouraged by the early results. Continuing follow-up on these patients will allow the medical community to assess the Nellix EVAS System's potential to significantly reduce the incidence of endoleak and need for secondary interventions, and further establish the role of this therapy in real-world practice."
Investor Meeting
Endologix will host an Investor Meeting from 5:00 to 7:30 pm ET on Thursday, November 20, 2014, at the New York Hilton Midtown. The event will include a Company update, presentations from prominent physicians, including clinical data from the EVAS FORWARD – Global Registry, and a question and answer session with the physicians and Endologix management.
| Event: | Endologix Investor Meeting |
| Date: | November 20, 2014 |
| Time: | 5:00 to 7:30 pm ET (registration and refreshments begin at 5:00 pm ET; formal presentation begins at 5:30 pm ET) |
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Location: |
Americas Hall II (updated room location), New York Hilton Midtown 1335 Avenue of the Americas, New York, NY |
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Physician Speakers: |
Professor Matthew Thompson, MD, St. Georges Vascular Institute, London Andrew Holden, MD, Associate Professor of Radiology at Auckland Hospital Christopher J. Kwolek, MD, Director, Vascular and Endovascular Training program at the Massachusetts General Hospital and Chief of Vascular Surgery at Newton Wellesley Hospital in Boston |
A live audio webcast of the investor meeting will be available by visiting the investor relations section of Endologix's website at www.endologix.com. Participants are encouraged to log on at a few minutes prior to 5:30 pm ET in order to download any applicable audio software. A replay of the presentation will be available within 24 hours and will be available for 30 days.
About Endologix, Inc.
Endologix, Inc. develops and manufactures minimally invasive treatments for aortic disorders. Endologix 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.
The Nellix® EndoVascular Aneurysm Sealing System has obtained CE Mark in the EU and is only approved as an investigational device in the United States.
Cautions Regarding Forward-Looking Statements
Except for historical information contained herein, this news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to the ability of the Nellix EVAS System to treat a broader range of patients, the potential of the Nellix EVAS System to become the leading therapy for the treatment of AAA, the timing of the next EVAS FORWARD –Global Registry data presentation, 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 difficulties in maintaining patient follow-up over a long-term and unanticipated clinical outcomes. 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, 2013, 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.