The Irvine, Calif.-based company said that data from the study showed that at least 28% more women are eligible for minimally-invasive EVAR with Endologix’s Ovation abdominal stent graft system compared to other EVAR systems.
The study enrolled 225 people, 76 women in the treatment group and 149 men in the control group, and the primary endpoint was the 30-day major adverse event rate. Secondary endpoints included serious and non-serious adverse events after one year.
Endologix reported that despite having more complex anatomy, women experienced similar outcomes to men following treatment with the Ovation device, including 100% freedom from AAA-related mortality compared to 98.6% in men. Freedom from reintervention for Type 1a endoleak was 98.6% in women and 97.9% in men, the company reported, and freedom from rupture and conversion was 100% across both groups.
Freedom from all device-related reintervention was 97.2% in both men and women, Endologix noted.
“Women have specific anatomical challenges in iliac access and proximal aortic neck morphology and have historically had worse outcomes from EVAR than men. The results of the LUCY study suggest that the unique features of the low-profile Ovation system may overcome these challenges and achieve similar outcomes in men and women,” Dr. Jennifer Ash, of the Christie Clinic Vein and Vascular Center, said in prepared remarks.
“We are excited to have completed follow-up on the Lucy study and are pleased that the one-year results suggest, for the first time in a prospective study, that female AAA patients can be treated with EVAR as effectively as men, when using the Ovation System. Lucy’s evidence provides physicians with new information to confidently engage female patients with prospectively derived outcomes previously realized only by male patients,” Endologix CEO John Onopchenko added.