Feb 14 2017
IRVINE, California (GLOBE NEWSWIRE)—Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that it has completed patient enrollment in the LUCY (Evaluation of FemaLes who are Underrepresented Candidates for Abdominal Aortic AneurYsm Repair) study, a multi-center post-market registry designed to explore the clinical benefits associated with endovascular aneurysm repair (EVAR) using the Ovation® Abdominal Stent Graft Platform in female patients with abdominal aortic aneurysms (“AAA”), as compared to males. It is the first prospective study evaluating EVAR in females, a population that has historically been underrepresented in EVAR clinical trials.
The LUCY study enrolled a total of 225 patients, including 75 females in the treatment group and 150 males in the control group, at 39 sites in the United States. The primary endpoint of the study is the 30-day Major Adverse Event (“MAE”) rate. The 30-day results from the LUCY study are anticipated to be presented at a medical meeting in the summer of 2017. The LUCY Study is led by an advisory board whose members include: Chairperson, Jennifer Ash, MD, Christie Clinic Vein and Vascular Center and Assistant Clinical Professor of Surgery University of Illinois College of Medicine, in Urbana-Champaign; and Members Venita Chandra, MD, Clinical Assistant Professor Surgery-Vascular Surgery, Stanford School of Medicine; Monica Hunter, MD, Birmingham Heart Clinic at St. Vincent’s, Birmingham; Eva Rzucidlo, MD, McLeod Vascular and Associate Professor of Surgery Geisel School of Medicine, Dartmouth; and Ageliki Vouyouka, MD, Associate Professor Surgery and Radiology, Mount Sinai Hospital.
Dr. Chandra commented, “Women have historically been underrepresented in EVAR clinical trials. One factor precluding women has been that traditional EVAR devices have been unable to accommodate the anatomic variances found in women, such as smaller access vessels and more challenging proximal aortic necks, compared to their male counterparts. The LUCY study is the first prospective study evaluating EVAR in a female population and it will make an important contribution to understanding the management and outcomes of women and other patients with similar anatomy.”
Dr. Ash added, “Retrospective analyses of women treated with traditional EVAR devices have consistently shown that women tend to have greater morbidity and mortality from EVAR intervention. Our preliminary analysis of the patients who have completed their 30-day follow-up visits suggest that women in the LUCY Study derived similarly favorable benefits from the Ovation Platform’s ultra-low profile delivery system and unique proximal sealing ring as compared to their male counterparts. We look forward to completing the patient follow-up and presenting the analysis at an upcoming meeting.”
John McDermott, Chief Executive Officer of Endologix, said, “The completion of enrollment in the LUCY study is another important milestone in our efforts to continue building the clinical evidence in support of our innovative portfolio of AAA products. It highlights our commitment to developing technologies that can improve clinical outcomes for AAA patients, including populations such as women that have historically been underserved with existing technologies. I would like to thank the clinical investigators and trial sites for their participation and support of this important clinical study.”
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 United States. 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 continued collection of clinical data and the anticipated results therein, 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, including difficulties in patient follow-up 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, 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.
John McDermott, CEO
Vaseem Mahboob, CFO