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Cook Medical Receives FDA Approval to Market Improved Zenith(R) AAA Iliac Flex Legs and Z-Trak(TM) Introduction System

August 4, 2008

Further innovating the field of advanced aortic disease repair technologies, Cook Medical today announced approval from the U.S. Food and Drug Administration (FDA) to market its improved Zenith Abdominal Aortic Aneurysm (AAA) Iliac Flex Legs and Z-Trak Introduction System, made for use with the Zenith Flex AAA Endovascular Graft. The products are designed specifically to provide increased flexibility and improved conformability in the aorta and iliac artery, a tortuous section of patient anatomy, for patients undergoing endovascular aneurysm repair (EVAR).

The Zenith AAA Flex Leg external stents are shorter than those of Cook Medical’s previous offering, with increased gaps between the stents. This design improves flexibility and conformability, reducing the potential of the leg to kink. The device, like the Zenith Flex main body, is constructed of polyester graft material supported by stainless steel Z-stent bodies. The Zenith Flex endograft main body with Flex Leg stents represents an important engineering achievement in the pursuit of improved outcomes for patients undergoing EVAR.

Cook’s revolutionary Z-Trak Introduction System provides an integrated interface to Cook’s market-leading device, continuing its established maneuverability for precise, controllable device orientation and deployment of the company’s endovascular stent graft. Precision is key to this system, allowing the operator to make last-minute adjustments prior to deployment of the stent graft, affording physicians the ability to achieve highly accurate placement. The trigger-wire delivery mechanism allows adjustment of the endograft in a semi-deployed state for pinpoint accuracy.

“FDA approval of the Z-Trak Introduction System and Zenith AAA Flex Leg brings the flexibility and deliverability of our market-leading AAA platform to U.S. physicians and their patients,” said Phil Nowell, global director of Cook’s Aortic Intervention strategic business unit. “Our commitment to creating innovative devices and technology to help physicians perform minimally invasive diagnostic and therapeutic procedures for aortic aneurysms that improve patient outcomes and make the benefits of EVAR available to an ever-widening cohort of patients is revolutionizing the industry and creating a new gold standard for the treatment of this life-threatening disease.”

Post-operative and post-discharge recovery times are typically shorter with EVAR which may help patients return to their normal lifestyle routines far faster than for those who undergo open surgery.

Availability

The Cook Zenith AAA Flex Leg and Z-Trak Introduction System are available in the United States as well as in continental Europe and the United Kingdom.

About Cook Medical

Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine. For more information, visit www.cookmedical.com.




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