Zenith Fenestrated device

Ventana device, 669 Zenith Fenestrated device, 665-8 premarket approval (PMA), 171 PremiCron, 295 Premilene, 300 pressure garment, 147-8 pressure-transverse strain elastic modulus, 410... 

Zenith Fenestrated device, 665-8,670 renal function after surgery, 668 stent graft showing fenestration supported by nitinol ring stent, 666... 

Currently there is only one prefenestrated endovascular stent-graft system approved by the FDA for use in the United States. It is an iteration of the Cook Zenith called the Cook Zenith Fenestrated . It is custom-made for each patient based on their personal aortic anatomy. This requires detailed CT scans of the abdominal aorta to properly locate the renal arteries and the superior mesenteric artery. The device is then manufactured with holes in the top piece for the renal arteries and a scallop at the top for the superior mesenteric artery (Fig. 21.19). These fenestrations are usually supported by a nitinol metal ring sewn around the circumference of the fenestration, as seen in the image taken from the study by Halak et al. (2006) (Fig. 21.20). 

Australian, British and American surgeons have looked at the intermediate results of the US trial for the fenestrated graft to evaluate the safety and shortterm effectiveness of the device.Thirty patients with short proximal necks were enrolled in the trial and treated with the Cook Zenith custom-fenestrated devices. None of the visceral arteries, renal or superior mesenteric, were lost as a result of the surgery. After 24 months there were no aneurysm-related deaths, ruptures, or conversions to open surgeries. There were 6 incidences of type II endoleak at 12 months and 4 at 24 months. In all patients the diameter... 

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