CE approval for advanced endovascular graft

Cook Incorporated, one of Cook Medical’s medical device manufacturing companies, has received CE approval for its new 36 mm Zenith Flex AAA Endovascular Graft for the treatment of abdominal aortic aneurysms (AAA).

This stateof- the-art aortic endograft is designed to provide an effective, minimally invasive treatment option for patients with large abdominal aortic neck diameters who previously may not have been candidates for endovascular aortic repair (EVAR).

AAA, a life-threatening disease diagnosed in tens of thousands of cases annually in Continental Europe and the UK, occurs when a section of the abdominal aorta, the body’s main circulatory vessel, weakens and bulges outward to forma fragile, balloon-like swelling called an aneurysm. If the aneurysm ruptures, the patient is at high risk of death as a result of internal bleeding.

With CE approval for Cook’s 36 mm Zenith Flex AAA Endovascular Graft preloaded onto the 22 French H&L-B One-Shot Introduction System with Flexor Sheath and Captor Hemostatic Valve, physicians in the EU now can offer an endovascular solution for the interventional treatment of AAA in large aortic necks ranging from 29 mm to 32 mm in diameter.

Dr Rod Chalmers, consultant vascular surgeon, Royal Infirmary of Edinburgh said: “This exciting development will allow us to treat patients with infra-renal aneurysms by endovascular means who would previously not have been suitable.”

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