Zenith Low Profile AAA Endovascular Graft receives CE mark

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Cook Medical has received CE mark approval for the Zenith Low Profile AAA Endovascular Graft (Zenith AAA LP).

 

The Zenith AAA LP device is significantly smaller than most commonly used EVAR delivery systems. The newly engineered stent graft is based on Cook Medical’s ARC technology, which combines a series of barbs that engage the aortic wall to provide active fixation, radial force from self-expanding z-stents for stability and optimal graft-to-vessel apposition, and a long main body with columnar strength that mimics the aorta’s natural anatomy.

Timothy Resch, consultant vascular surgeon, Skåne University Hospital in Sweden involved in the initial trials of the Zenith AAA LP, said, “While EVAR has gained huge popularity in recent times for the treatment of abdominal aortic aneurysms, the technique cannot be used for certain subsets of patients. The alternative is traumatic open surgery, which can be a major burden or indeed completely unsuitable for frail or elderly patients due to long recovery times. Technologies that aim to address this niche help us provide endovascular treatment options for more and more patients.”

With its low profile delivery system, the Zenith AAA LP represents a breakthrough for surgeons treating patients with difficult or tortuous arterial access who might otherwise have been ineligible for EVAR. This patient group includes many women and smaller-bodied adults whose more narrow and angulated arteries can impede the accurate positioning of an endovascular graft using currently available larger-diameter delivery systems.

 

The advanced technology device will be available initially at 20 European centres where the company will conduct a registry intended to capture patient outcome data for later publication. A full rollout of the device to all European physicians is planned for Q3 2010.