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First-in-man use for new generation aortic aneurysm endograft system

Cook : 06 June, 2008  (New Product)
Cook Medical has announced its first-in-man use application of a smaller endograft system.
The successful case was the first human use of Cook's new Zenith Low Profile AAA Endograft System. Early reports indicate the new system, which uses more highly compressible Z-stent bodies instead of the existing stents used in the current Zenith Flex endografts, exceeded physician expectations.

“The successful development of this device will benefit TAA and AAA patients around the world for whom no endovascular treatment option currently exists,” explained Phil Nowell, global leader of Cook Medical's Aortic Intervention business unit. “The Zenith Low Profile represents yet another step forward by Cook Medical to provide physicians with the most advanced tools possible for the treatment of aortic disease in all its manifestations.”

The device miniaturisation development continues Cook's ongoing pursuit of developing technologies aimed at helping physicians perform minimally invasive diagnostic and therapeutic procedures with the least possible trauma to the patient.

Currently, delivery systems for endografts to treat aneurysms in the abdominal and thoracic regions of the aorta must be inserted through incisions in the femoral arteries because they are most often too large in diameter to be easily inserted percutaneously. The larger diameter sheath also means the device is stiffer, making it more difficult to negotiate through narrow, tightly curved arteries to reach the diseased section of the aorta where the endograft needs to be deployed. In addition, in smaller patients the vascular anatomy may be too small to accept the current generation of larger-sized delivery systems.

The Zenith Low Profile AAA Endograft System addresses those areas of concern by reducing the size of the delivery sheath to 16 French. This development, if proven safe and effective in an upcoming clinical trial, could open endovascular treatment of aneurysms to a new class of patients who currently have only open surgery as a treatment option due to the small diameter of their blood vessels and other anatomic issues. In addition, it may enable physicians to eliminate the need for a surgical cut down to access the femoral artery and allow the use of the percutaneous entry technique where a needle is inserted to allow the guidewire and delivery sheath to enter the artery with far less trauma.
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