Endologix Reports 30-Day Data From the Ovation LUCY Study
May 31, 2017—Endologix, Inc. announced 30-day results from the LUCY study, which is an evaluation of endovascular aneurysm repair (EVAR) using the company's ultra-low-profile (14-F) Ovation abdominal stent graft system in women with abdominal aortic aneurysms (AAAs). In February, the company announced completion of patient enrollment in LUCY.
According to Endologix, the 14-F Ovation system is designed to better suit female anatomy than traditional EVAR options. The LUCY study specifically evaluated EVAR outcomes in women, who have historically been underrepresented in EVAR clinical trials. The data demonstrated lower mortality and complications when compared to previous EVAR studies.
The LUCY study is a prospective, consecutively enrolling, nonrandomized, multicenter, postmarket registry. The study is led by an advisory board chaired by Jennifer Ash, MD, who is with the Christie Clinic Vein and Vascular Center and Assistant Clinical Professor of Surgery at the University of Illinois College of Medicine in Champaign, Illinois.
A total of 225 patients, including 76 women in the treatment group and 149 men in the control group, were enrolled at 39 sites in the United States. The primary endpoint of the study was the 30-day major adverse event (MAE) rate. Longer-term data from the LUCY study will be reported after the 1-year follow-up.
The 30-day LUCY data showed that treatment of women with the 14-F Ovation device resulted in at least a 28% greater EVAR eligibility for women with AAAs, 1.3% MAE rate, no deaths, no proximal endoleaks, no limb occlusions, a low readmission rate of 3.9%, and 100% procedural success rate.
In the company's press release, Marc Schermerhorn, MD, commented, “Analysis of historical EVAR clinical data is showing us a large unmet need for AAA treatments for women. Women are less prone to develop the disease, but, when they do, they have significantly worse outcomes than men. New treatment options that better accommodate female anatomy, thereby increasing access and improving outcomes, may go a long way in rectifying the gender disparity in AAA treatment.” Dr. Schermerhorn is Associate Professor of Surgery at Beth Israel Deaconess Medical Center in Boston, Massachusetts.
Venita Chandra, MD, added, "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.” Dr. Chandra is Clinical Assistant Professor of Surgery-Vascular Surgery at Stanford School of Medicine in Stanford, California.