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news.Cook Incorporated has filed an investigational device exemption for a new type of endograft designed to treat patients with aortoiliac or iliac aneurysms that have been difficult to treat endovascularly with currently available designs.
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The company has asked the FDA for permission to initiate a clinical trial of the Zenith Branch Endovascular Graft-Iliac Bifurcation with the H&L-B One Shot Introduction System at 10 sites. The trial is expected to take about one year to enroll.
Barry Thomas, vice president of aortic intervention business unit at Cook Medical, said: “With the Zenith Branch Endovascular Graft, we can extend the same advanced endograft technology currently available for treating abdominal and thoracic aneurysms to a new class of patient whose aneurysm extends into the iliac arteries.”