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news.Cook Medical has reported positive results from a non-randomized, controlled study on the Cook Zenith abdominal aortic aneurysm endovascular graft for endovascular aortic repair.
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The trial results indicated that the endovascular aortic repair (EVAR) procedure, using the Cook Zenith, is a safe and effective alternative to open surgical repair for the treatment of abdominal aortic aneurysms (AAAs).
The study compared the minimally invasive EVAR procedure using the Cook Zenith device to a control group that underwent open surgical repair to treat abdominal aortic aneurysms. The middle- and long-term data evaluating the Cook Zenith AAA endovascular graft found long-term durability, a significantly low risk of aneurysm-related death or rupture, and infrequent complications of migration, limb occlusion and device integrity issues.
Specifically, the study demonstrated that for Zenith patients at standard and high medical risk, aneurysm-related death was two percent and four percent; and freedom from rupture was 100% and 99.6%, respectively.
Phil Nowell, global leader of Cook Medical’s Aortic Intervention strategic business unit, said: “This positive, five-year clinical data serves as yet another proof point that our advanced Zenith design, coupled with the minimally-invasive EVAR procedure, provides patients with the best combination of medical technology to treat abdominal aortic aneurysms.”