Cook Medical announced that FDA has granted breakthrough device designation for its Zenith Fenestrated+ endovascular graft (ZFEN+), the next-gen version of its Zenith Fenestrated AAA endovascular graft.
The designation — a first for Bloomington, Ind.–based Cook Medical — will enable priority review and better communication with FDA during the clinical trial and premarket review phases. Cook plans to seek an investigational device exemption approval in the coming months, with a pivotal clinical study starting later this year.
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