Cook Medical's Zenith Spiral-Z AAA iliac leg graft receives FDA premarket approval

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

"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.

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.

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.