Cook Medical’s Zenith Spiral-Z AAA Iliac Leg Graft Gets FDA PMA

Cook Medical has received FDA premarket approval for the Zenith Spiral-Z AAA Iliac Leg Graft. The device provides graft support in the iliac artery in patients with abdominal aortic aneurysms.

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.

Press release: Cook Medical Receives FDA Approval for Iliac Leg Graft