Endologix Completes Patient Enrollment in the Ovation® LIFE (Least Invasive Fast-Track EVAR) Study
IRVINE, Calif., May 16, 2016 (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 LIFE study, a multi-center post-market registry designed to evaluate the Ovation ® Abdominal Stent Graft Platform when used in the treatment of patients with abdominal aortic aneurysms ("AAA") using a Fast-Track EVAR protocol. The LIFE study is the first of its kind using a Fast-Track EVAR protocol, which includes bi-lateral percutaneous access enabled by the Ovation Platform ultra-low profile (14F) design, avoidance of general anesthesia and intensive care unit (“ICU”) admission post procedure, and next-day discharge.
The LIFE study enrolled 250 patients at 34 sites in the United States. The primary endpoint of the study is the 30-day Major Adverse Event (“MAE”) rate. The results from the LIFE study are anticipated to be presented at a medical meeting in the fall 2016. The LIFE Study is led by national principal investigators Zvonimir Krajcer, MD, FACC, Co-Director, Peripheral Vascular Disease Service at Texas Heart Institute in Houston, Texas and Venkatesh G. Ramaiah, MD, FACS, Director of Research at the Arizona Heart Institute and Medical Director of the Arizona Heart Hospital in Phoenix, Arizona.
Dr. Krajcer commented, “The LIFE study provides us the ability to risk stratify AAA patients and offer them a Fast-Track option which is compelling for patients, physicians and the hospital. The preliminary data presented in November 2015 demonstrated a meaningful reduction in procedure time and length of stay, which should translate into measurable cost-savings and higher patient satisfaction. We look forward to completing the patient follow-up and data-analysis and presenting the results at an upcoming medical meeting.”
Dr. Ramaiah said, “Traditionally, EVAR procedures have required surgical exposure of the common femoral artery to gain endovascular access to the diseased aorta. While this is significantly less invasive than an open surgical approach, it often requires more than one night in the hospital due to the use of general anesthesia and subsequent ICU stay. The Fast-Track EVAR option utilizes the least invasive approach via bi-lateral percutaneous access and is enabled by the Ovation Platform’s ultra-low profile (14F) design. The preliminary data from the LIFE study are encouraging and suggest that the Fast-Track with the Ovation Platform is feasible, safe, and may improve efficiency of healthcare resource allocation in patients undergoing EVAR.”
John McDermott, Chairman and Chief Executive Officer of Endologix, said, “The completion of enrollment in the LIFE study is another important milestone in our efforts to continue building the clinical and economic evidence in support of our portfolio of AAA products. I would like to thank the clinical investigators and trial sites for their support and efforts to bring the Fast-Track EVAR option to AAA patients.”
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 final data acquired through the LIFE study, and the adoption of bi-lateral percutaneous access by clinicians, 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 results from follow-up of subjects in the LIFE study. 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.