Cook Medical receives US FDA approval for aortic dissection device

Zenith Endovascular Dissection System (Cook Medical)

Cook Medical has announced its recent approval from the US Food and Drug Administration (FDA) for its Zenith endovascular aortic dissection system.

The system, consisting of a proximal stent-graft component and a distal bare stent component, provides physicians a less invasive alternative to open surgery for repair of Type B aortic dissection of the descending thoracic aorta. The device will be available for sale in the USA in the coming months, the company states in a press release.

“We are pleased to provide another minimally invasive option for aortic repair,” says Mark Breedlove, vice president of Cook Medical’s Vascular division. “The approval of this product gives us an opportunity to have a positive impact on the lives of patients with aortic dissections.”

“Cook Medical is committed to developing a variety of treatment options for aortic disease—from the arch to the iliacs, in order to help physicians fit a device to each patient’s unique disease state,” Breedlove says.


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