Aortic disorder specialist Endologix, Inc., has announced 30-day study results showing that at least 28 percent more women became eligible for minimally-invasive endovascular aneurysm repair (EVAR) when using the Ovation® Abdominal Stent Graft System, compared with traditional EVAR options.
Recent clinical articles in The Lancet and the Journal of Vascular Surgery indicate that aneurysms grow faster in women than men, leading to a higher rate of rupture and death. Female anatomy may also be more challenging for most commercial EVAR treatments, leading to less eligibility for EVAR and greater mortality, major complications, and readmissions, when compared to men.
The Endologix 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 new data has come from the LUCY (Evaluation of FemaLes who are Underrepresented Candidates for Abdominal Aortic AneurYsm Repair) study. The LUCY study is the first to specifically evaluate EVAR outcomes in women, who have historically been underrepresented in EVAR clinical trials.
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 (“MAE”) rate. Longer-term data from the LUCY study will be shared after the one-year follow-up.
The 30-day LUCY data showed that, in women, the ultra-low profile (14F) Ovation device resulted in 100% procedural success, with at least 28 percent greater EVAR eligibility, a low (1.3%) incidence of major adverse events, no deaths, no proximal endoleaks, no limb occlusion and a low readmission rate of 3.9 percent.
Marc Schermerhorn, MD, Associate Professor of Surgery, Beth Israel Deaconess Medical Center, said, “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.”
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.”
John McDermott, Chief Executive Officer of Endologix, commented, “We are very pleased with the early LUCY study results, which demonstrate the potential Ovation offers to enable more effective treatment of female AAA patients and significantly improved outcomes for all patients. We look forward to expanding Ovation’s access to more women in those regions where it is available, and to educating both the clinical community and patients about the unique needs of the female patient and the treatment options that are optimized for them.”
Source: Endologix, Inc.