Medtronic received the EU CE Mark for its Endurant II/IIs stent grafts to be used to treat abdominal aortic aneurysms (AAA) using the ChEVAR technique (chimney technique in endovascular aortic aneurysm repair). ChEVAR can be particularly useful in timely situations to avoid having to produce patient customized branched and fenestrated stent grafts, as well as for use in patients with short aortic necks.
ChEVAR essentially relies on placing traditional stents or stent grafts linking the main artery with the side branches, and positioning the main stent graft within the aorta and pressing against the side branch stents (see picture).
Some details about the study that led to the approval, according to Medtronic:
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.