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Cook's Zenith AAA Iliac Flex Legs achieves first-in-man placement

Cook : 28 August, 2008  (Company News)
Cook Medical has announced the first-in-man placement of its innovative Zenith AAA Iliac Flex Legs and Z-Trak Introduction System.
The procedure was performed by David Ratliff, consultant vascular surgeon, and Dr Davis Thomas, a radiologist specialising in vascular and non-vascular interventional radiology at Northampton General Hospital. The patient, a 85-year-old man, experienced no complications and has been discharged from the hospital.

Cook has engineered the new Zenith AAA Iliac Flex Legs specifically for greater flexibility and increased conformability in the aorta and iliac arteries during endovascular aneurysm repair (EVAR). The legs' increased flexibility, along with the enhanced capabilities of the new delivery system, ease the device's passage through tortuous patient anatomy. The device is the latest addition to Cook's industry-leading suite of endovascular aortic repair (EVAR) devices and recently received CE marking for use in Europe and US Food and Drug Administration approval for sale in the USA.

On completing the pioneering procedure, Dr Thomas said: “Simplicity is the key to device evolution. The Zenith system's hydrophilic main body sheath and increased flexibility makes deployment through tortuous iliac vessels much simpler. It's easier for the surgeon to place, and reduces the risk to patients. The increased flexibility should help to increase the number of patients suitable for minimally invasive endovascular repair.”

The Zenith AAA Iliac Flex Leg's external stents are shorter than those of its predecessor, with increased gaps between the stents. The device, like the Zenith Flex main body, is a handcrafted tubular component constructed of polyester Graft material supported by self-expanding stainless steel Z-stent bodies. Together, the devices are used to treat abdominal aortic aneurysm (AAA), an abnormal weakening of the aortic wall that causes it to bulge and balloon outward. Should the aneurysmal sac rupture, the patient would be at high risk of death. Endovascular treatment eliminates the need for highly traumatic open surgical repair of the aneurysm, offering aneurysm patients significantly shorter hospital stays and recovery periods, while improving patient mortality rates over conventional surgery.

Phil Nowell, global leader of Cook Medical's Aortic Intervention business unit explained: “The Zenith Flex endograft main body represents an important engineering achievement in the pursuit of improved outcomes for patients undergoing EVAR. But until now, no endovascular device company has addressed the issue of dramatically improving the other components - the ipsilateral and contralateral legs that seal the main body of the endograft below the aortic bifurcation.”

“Like the Zenith Flex main body, the development of the Zenith AAA Iliac Flex Legs is another step in Cook's efforts to create a comprehensive set of innovative technologies that allow physicians to better perform minimally invasive diagnostic and therapeutic procedures with reduced risk of trauma to the patient and improved long-term clinical outcomes.”
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