Sunday 17 August 2008

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

�Further innovating the field of innovative aortic disease repair technologies, Cook Medical 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 general anatomy, for patients undergoing endovascular aneurysm bushel (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 potentiality of the leg to kink. The device, like the Zenith Flex independent body, is constructed of polyester graft material supported by stainless steel steel Z-stent bodies. The Zenith Flex endograft main body with Flex Leg stents represents an important engineering accomplishment 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, governable device predilection and deployment of the company's endovascular stent graft. Precision is key to this organisation, allowing the operator to make last minute adjustments prior to deployment of the stent graft, affording physicians the ability to attain highly accurate placement. The trigger-wire livery 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," aforesaid 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 therapeutical procedures for aortic aneurysms that meliorate patient outcomes and nominate 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 quicker than for those world Health Organization undergo open surgery.

Availability


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

About Cook Medical


Cook Medical was one of the first companies to help popularise interventional music, 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 biotechnology to enhance patient guard and improve clinical outcomes in the fields of aortic intercession; interventional cardiology; critical forethought medicine; gastroenterology; radiology, peripheral vascular, os access and oncology; surgical process and soft tissue furbish up; urology; and assisted generative technology, gynaecology and high-risk obstetrics. Cook is a past succeeder of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine.

Cook Medical


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