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Zenith Fenestrated Cook Medical Form
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People also ask
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What is the cook Z Fen device?
The device is intended for use in the endovascular treatment of patients with aortic aneurysms for whom the graft seal zone requires fenestrations and involves one or more of the major visceral vessels: celiac artery, superior mesenteric artery, and/or renal arteries.
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Are aortic stent grafts MRI safe?
Non-clinical testing has demonstrated that the Endurant II Stent Graft is MR Conditional. It can be scanned safely in both 1.5T & 3.0T MR systems under certain conditions as described in the product Instructions for Use. For additional information regarding MRI please refer to the product Instructions for Use.
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Is Cook Zenith Flex MRI safe?
There have been no reported adverse events or device problems in any of these patients as a result of having received an MRI. Additionally, there have been well over 100,000 Zenith AAA Endovascular Grafts implanted worldwide, in which there have been no reported adverse events or device problems as a result of MRI.
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What is the CPT code for fenestrated stent graft?
CPT® Code 34845 - Fenestrated Endovascular Repair Procedures of the Visceral and Infrarenal Aorta - Codify by AAPC.
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What is the breakthrough designation of cook medical?
January 21, 2022—Cook Medical announced it has received Breakthrough Device designation from the FDA on a new drug-eluting stent (DES) for below-the-knee (BTK) application. The device is designed to treat patients with chronic limb-threatening ischemia (CLTI).
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Is cook zenith graft MRI safe?
The presence of a Zenith stent graft is regarded as a contraindication to MRI because the stents are made of 304 stainless steel.
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What is the material of the zenith graft?
The device is made of stainless steel, self-expanding Z-stents and polyester fabric.
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What is a Zenith Flex AAA endovascular graft?
The Zenith Flex AAA Endovascular Graft is designed for the treatment of patients with abdominal aortic or aorto-iliac aneurysms who are deemed suitable for EVAR procedures.
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