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Medical Devices / Submissions and Approvals

FDA Approves Cook Medical’s Dissection Endovascular Device

Feb. 7, 2019
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The FDA approved Cook Medical’s Zenith dissection endovascular system for repairing a part of the aorta.

The device offers physicians an alternative to open surgery for repairing Type B dissections of the lower thoracic aorta, an area of the aorta that is located in the thorax. It will be on sale in the US “in the coming months,” the company said.

The Zenith system is composed of a proximal stent-graft and a distal bare stent and is less invasive than open surgery.

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