It is designed for flexibility in the iliac arteries during endovascular aneurysm repair (EVAR) and is kink resistant. As you can read below the device already has the European CE Mark. We seen to be seeing quite a few of these of late with Europe ahead of the FDA with many devices and drugs. BD
Bloomington, Ind., July 12, 2011 – 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 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.
About Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs, cell therapy and biologic grafts to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit www.cookmedical.com <http://www.cookmedical.com/>.