Medtronic touts Endurant stent graft data from Engage study
Medtronic (NYSE:MDT) touted data from a series of sub-group analyses from the 10-year 1,200-patient Engage study of its Endurant II and Endurant IIs stent grafts for treating abdominal aortic aneurysms last week at the annual Veith Symposium on vascular disease.
First-time results from a review of the occurrence of endoleaks at the aneurysm neck, presented by Dr. Hence Verhagen of Erasmus University Medical Center in Rotterdam, Holland, showed a 97.8% rate of freedom from Type Ia endoleaks at 1 year. The rate was 97.3% at 2, 96.7% at 3 years and 96% at 4 years.
“The impact of a Type Ia endoleak is serious and includes an increased risk of rupture and the need for re-intervention. This new analysis from the four-year global Engage registry provides further evidence of the benefits of [endovascular aneurysm repair] in patients with both standard and complex anatomies, and it reflects the low endoleak rates that can be achieved with the Endurant stent graft system,” Verhagen said in prepared remarks.
Another sub-group review by Verhagen examining 100 patients with “hostile” aortic neck anatomies showed “positive” outcomes at 4 years for aneurysm-related mortality, rupture and conversion to open surgical repair.
A 3rd analysis, comparing results from Engage with data from the EVAR 1 study comparing 1st-generation stent grafts with open surgical repair. Presented by Dr. Dittmar Böckler of the University of Heidelberg, showed 54% relative risk reduction in aneurysm-related mortality, a 44% relative risk reduction of rupture and a 35% relative risk reduction in secondary interventions.
“The Endurant stent graft system is a great example of Medtronic’s commitment to work together with clinicians to provide patients with clinically driven, life-saving technology. With more than 250,000 successful implants, our leadership in EVAR is supported by deep clinical experience,” aortic general manager Daveen Chopra said in prepared remarks. “The data from the Engage registry presented at Veith Symposium adds to the unmatched clinical experience of Endurant, further demonstrating why it provides physicians with a durable and effective solution to treat more patients, including those with both standard and complex anatomies.”