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Cook Medical wins FDA breakthrough device designation for next-gen endovascular graft

March 2, 2021 By Chris Newmarker

Cook MedicalCook 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.

Zenith Fenestrated AAA endovascular graft Cook Medical
The existing Zenith Fenestrated AAA endovascular graft [Image courtesy of Cook Medical]
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.

 

 

Filed Under: Product Development Tagged With: Cook Medical, stents

About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.

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