FDA clears iliac leg graft for the treatment of abdominal aortic aneurysms


The Food and Drug Administration (FDA) has given premarket approval (PMA) to Cook Medical for its Zenith Spiral-Z AAA Iliac Leg Graft.  The device is indicated for use in patients with abdominal aortic aneurysms that require graft support in the iliac artery. 

Zenith Spiral-Z features enhanced flexibility and kink resistance due to a continuous nitinol spiral stent. It also offers increased radial force at the proximal sealing site with Cook Medical’s latest technology in sealing stent design. The Zenith device’s Z-Trak introduction system features a PTFE-coated lumen to reduce surface friction and facilitate precise device delivery.

“Zenith Spiral-Z provides physicians with Cook’s most kink-resistant and trackable iliac leg graft to date,” said Phil Nowell, vice president of Cook Medical’s Aortic Intervention division.

As part of Cook Medical’s Zenith Flex AAA Endovascular Graft product line, Zenith Spiral-Z was launched in Europe following CE mark approval in April 2011.