Endologix touts 30-day data from study of Ovation stent graft in women

Endologix (NSDQ:ELGX) touted 30-day data today from a trial evaluating its Ovation abdominal stent graft system in women. 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...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Vascular Women's Health Endologix Source Type: news