Medtronic touts 5-year gendered sub-analysis data from Endurant AAA stent graft trial

Medtronic (NYSE:MDT) today released new 5-year data from a gender separated subset of the Engage trial of its Endurant II abdominal aortic aneurysm stent graft system. The subset analysis aimed to compare results across both male and female patients. Fridley, Minn.-based Medtronic said that historically, women have had worse EVAR outcomes than men due to anatomy differences, including more angulated aortic necks and smaller aneurysms and iliac vessels. The analysis included 1,263 patients, with 133 female and 1,130 males. For women in the study, data indicated a 99.2% rate of successful delivery and eployment, only 0.3% lower than the 99.5% reported in men. Freedom from aneurysm-related mortalities in females were reported at 100%, slightly ahead of the 97.5% rate reported for men. Type Ia endoleaks were reported in 3.8% of females, lower than the 1.3% rate reported in males. Freedom from secondary procedures between men and women were similar, at 84.1% and 85.6%, respectively. Stabiliziation or decreases in aneurysm sacs were nearly identical, at 89.6% for females and 89.4% for males, according to the data. Women reportedly had a 100% rate of freedom from rupture, versus a lower 98.4% rate in men. “It is well known in the clinical community that women have not benefitted to the same extent as men when receiving an EVAR procedure, and in turn, have become a greatly underserved patient population. Endurant is now the only stent graft system to close the outcomes gap bet...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Vascular Medtronic Source Type: news