Cook Receives Approval for Improved Zenith AAA Iliac Flex Legs, Z-Trak Introduction System


August 5, 2008

August 5, 2008 - Cook Medical today said the FDA approved 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 said its Z-Trak introduction system provides an integrated interface to 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, Cook said. The trigger-wire delivery mechanism allows adjustment of the endograft in a semi-deployed state for pinpoint accuracy.

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, the company said.

The Cook Zenith AAA Flex Leg and Z-Trak Introduction System are available in the U.S. as well as in continental Europe and the U.K.

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