Minimally Invasive AAA Treatment Cleared in U.S.

The FDA has granted approval to Cook Inc. for its new 36mm Zenith FLEX AAA Endovascular Graft for the treatment of abdominal aortic aneurysms (AAA), according to Cook press release. The state-of-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).

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

Cook’s Zenith AAA endograft is the world’s largest-selling device of its kind and currently is in use in the U.S., Canada, Japan, the European Union, Australia, Latin America and other major markets.