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July 11, 2011
FDA Approves Cook Medical's Spiral-Z Iliac Leg Graft
July 12, 2011—Cook Medical (Bloomington, IN) announced that it has received premarket approval from the US Food and Drug Administration for its Zenith Spiral-Z abdominal aortic aneurysm (AAA) iliac leg graft. The device is indicated for use in patients with AAAs requiring graft support in the iliac artery.
According to the company, the Zenith Spiral-Z features a continuous nitinol spiral stent that provides enhanced flexibility and kink resistance. Cook Medical's sealing stent technology offers increased radial force at the proximal sealing site, and the Zenith device's Z-Trak introduction system features a polytetrafluoroethylene-coated lumen to reduce surface friction and facilitate precise device delivery.
The Zenith Spiral-Z is part of Cook Medical's Zenith Flex AAA endovascular graft product line. The device was launched in Europe after receiving CE Mark approval in April 2011.
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