The Lucy trial showed that at least 28% more women became eligible for minimally-invasive endovascular aneurysm repair when using the Ovation stent graft. The study is the 1st to assess endovascular aneurysm repair outcomes in women, according to Endologix.
Previous research has shown that aneurysms grow faster in women compared to men and that female anatomy is more challenging for most traditional treatment methods.
The company’s 225-patient trial included 76 females in the treatment group and 149 males in the control group. The primary endpoint was the 30-day major adverse event rate.
Interim data from the Lucy trial showed that the ultra-low profile Ovation device had a 1.3% rate of major adverse events, which Endologix said is the lowest rate reported for endovascular aneurysm repair options. The study also had no deaths, no proximal endoleaks, no limb occlusion and a readmission rate of 3.9%.
“Analysis of historical EVAR clinical data is showing us a large unmet need for AAA treatments for women,” Dr. Marc Schermerhorn of Beth Israel Deaconess Medical Center said in prepared remarks.”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.”
“It is gratifying to see better early outcomes for women in the Lucy study,” Dr. Venita Chandra, from Stanford School of Medicine, added. “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.”
“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,” CEO John McDermott said. “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.”