Endologix Reports Positive Clinical Data From Ovation LUCY Study

(RTTNews) - Endologix, Inc. (ELGX), a developer of innovative treatments for aortic disorders, announced late Wednesday positive clinical data from the Ovation LUCY study.

As per the 30-day results from the LUCY (Evaluation of FemaLes who are Underrepresented Candidates for Abdominal Aortic AneurYsm Repair) study, at least 28% more women became eligible for minimally-invasive endovascular aneurysm repair or EVAR when using the Ovation Abdominal Stent Graft System.

The company noted that Ovation System is designed to better suit female anatomy than traditional EVAR options and demonstrated lower mortality and complications when compared to previous EVAR studies.

The LUCY study is a prospective, consecutively enrolling, non-randomized, multi-center, post-market registry evaluating the Ovation Platform for the endovascular treatment of AAA in women. The study enrolled a total of 225 patients, including 76 females in the treatment group and 149 males in the control group, at 39 sites in the U.S.

The primary endpoint of the study was the 30-day Major Adverse Event or MAE rate. Longer-term data from the LUCY study will be shared after the one-year follow-up.

The LUCY study is the first to specifically evaluate EVAR outcomes in women, who have historically been underrepresented in EVAR clinical trials.

Venita Chandra, MD, Clinical Assistant Professor of Surgery-Vascular Surgery, Stanford School of Medicine, said, "It is gratifying to see better early outcomes for women in the LUCY study. The Ovation device was able to accommodate the particular challenges of female anatomy, such as small access vessel diameter, short neck length, and higher neck angulation. In addition, mortality, major adverse events, and readmissions were improved for both sexes. I look forward to assessing the durability of these results over the longer term.