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.
“Cook has continued innovating even through the pandemic, building on years of physician feedback and patient outcomes on our current Zenith platform. This breakthrough device designation is a sign of our innovation and commitment to treating critically ill patients,” Mark Breedlove, VP of Cook Medical’s Vascular division, said in a news release posted yesterday.The ZFEN+ is meant for endovascular treatment of patients with aortic aneurysms where the graft seal zone requires fenestrations and involves one or more of the major visceral vessels, which include the celiac artery, superior mesenteric artery and renal arteries.
The ZFEN+ has up to five precisely located fenestrations to accommodate the visceral vessels. The extra customization allows tailoring of the graft to better fit a persons unique anatomy, maximizing the seal zone to exclude the aneurysm.