Posted by Michael Wonder on 02 Mar 2021
Cook Medical receives FDA breakthrough device designation for Zenith fenestrated+ endovascular graft
1 March 2021 - Cook Medical’s Zenith fenestrated+ endovascular graft product has received breakthrough device designation from the US FDA.
While the product is not commercially available yet, the benefits of the designation include priority review and interactive and timely communication with FDA during the clinical trial and premarket review phases in order to help get lifesaving devices to patients more quickly.
The Zenith fenestrated+ endovascular graft is the first product from Cook Medical to receive a breakthrough device designation.
