IRVINE, Calif.--(BUSINESS WIRE)--Endologix, Inc. (NASDAQ:ELGX), a developer and marketer of innovative treatments for aortic disorders, today announced positive interim results from the LEOPARD (Looking at Evar Outcomes by Primary Analysis of Randomized Data) clinical study. LEOPARD is the first and only head-to-head, prospective, multi-center, randomized clinical study comparing currently available endovascular abdominal aortic stent grafts. LEOPARD directly compares the Endologix AFX® and AFX2 endografts to other commercially available bifurcated aortic endografts.
LEOPARD was initiated in 2015 and has since randomized 458 patients. The primary endpoint in the study is freedom from Aneurysm Related Complications (“ARC”), such as aneurysm rupture, conversion to open repair, endoleaks, migration, aneurysm enlargement and secondary interventions. Based upon the patients that have completed their one-year follow-up, freedom from ARC with AFX/AFX2 is 84.7%, compared to 82.0% with the other devices. These preliminary results demonstrate similar outcomes between the endografts under investigation, but there is a trend towards better performance for AFX/AFX2, which is the only device that preserves the patient’s aortic bifurcation. Based upon the anticipated number of additional patients required to prove superiority, Endologix plans to stop further randomization in the LEOPARD study and continue to follow enrolled patients for the planned five years.
“The results from this analysis are very encouraging. In particular, we are pleased with the trend towards lower rates of endoleaks, limb occlusions and secondary interventions with AFX/AFX2, along with the absence of Type 3 endoleaks,” commented John McDermott, Endologix’s Chief Executive Officer. “We’d like to thank our investigators for participating in this important clinical study and look forward to presenting the final one-year results next year after all patients have completed their follow-up.”
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. For more information, visit www.endologix.com.
Cautions Regarding Forward-Looking Statements
Except for historical information contained herein, this press release contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking
statements generally can be identified by the use of words such as “anticipate,” “expect,” ‘plan,’ “could,” “may,”“will,” “believe,” “estimate,” “forecast,” “goal,” “project,” "continue," "outlook," “guidance,” "future,” other words of similar meaning and the use of future dates. Forward-looking statements used in this press release include, but are not limited to, statements regarding the continuation of the LEOPARD study and presentation of further results, the accuracy of which are necessarily subject to risks and uncertainties that may cause future events to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ materially and adversely include Endologix’s ability to continue to follow-up on patients in the LEOPARD trial. Undue reliance should not be placed upon the forward-looking statements contained in this press release, which speak only as of the date of this press release. Endologix undertakes no obligation to update any forward- looking statements contained in this press release 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 filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2016, for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied.