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AAA Stent Graft System Obtains CE Mark
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The Endurant II AAA Stent Graft System has landed a CE mark, expanding the options for physicians outside of the United States who perform endovascular aortic repair of abdominal aortic aneurysms.
According to a press release issued by the manufacturer (Medtronic), the Endurant II AAA Stent Graft System was developed in collaboration with more than 250 physicians worldwide. It is indicated for the endovascular treatment of abdominal aortic aneurysms (AAA) in patients with a proximal neck at least 10 mm in length with no more than 60 degrees infrarenal and 45 degrees suprarenal angulation, as well as in patients with a proximal aortic neck at least 15 mm in length with no more than 75 degrees infrarenal and 60 degrees suprarenal angulation.
The system adds three features to its earlier model (Endurant AAA Stent Graft System) to enhance ease of use, the release stated: a lower profile deliver system that allows the 28-mm diameter bifurcated segment to fit inside an 18F outer diameter catheter (down from 20F with the original device); the addition of two new contralateral limb lengths (156 mm and 199 mm) for more configuration options requiring fewer total pieces; and improvements to the radiopacity of the distal end of the bifurcated segment’s contralateral gate for enhanced visibility and aid with limb insertion, placement and deployment.
The FDA approval for the Endurant II AAA Stent Graft System is expected sometime this year.