Endurant II/IIs stent graft system receives CE mark approval for expanded indication in abdominal aortic aneurysm- Medtronic

Medtronic announced that it has received CE Mark for the Endurant II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) patients using a ChEVAR procedure, a parallel graft chimney technique that uses commercially available balloon expandable covered stents combined with a standard aortic stent graft. This expanded indication in the European Union enables the Endurant II/IIs stent graft system to be used in patients with complex aneurysms with short aortic neck lengths of at least 2 mm, expanded from the prior neck length indication greater than 10 mm.

The CE Mark is supported by a comprehensive review of clinical data from literature using the Endurant II/IIs stent graft system with the ChEVAR technique. In the flagship PROTAGORAS study, outcomes were tracked with radiologic follow up over a mean of two years. The study used a standardized procedural approach with the Endurant system and balloon expandable covered stents. The results, which were published in the Journal of Vascular Surgery, demonstrated that standardized use of the Endurant II/IIs stent graft system with ChEVAR in 128 patients is associated with 100 percent technical success, statistically significant aneurysm sac regression (p = .001), 95.7 percent primary patency of the chimney grafts and a low incidence of chimney related reinterventions.