Bloomington, Ind. — Cook Medical’s Zenith® Fenestrated+ Endovascular Graft (ZFEN+) product has received Breakthrough Device designation from the US Food and Drug Administration (FDA). This designation is granted for devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. 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 ZFEN+ is the first product from Cook Medical to receive a Breakthrough Device designation.
“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,” said Mark Breedlove, vice president of Cook Medical’s Vascular division.
The ZFEN+ is built on the strength of the proven Zenith platform and represents the next generation of our Zenith Fenestrated AAA Endovascular Graft. The product is intended for use in the endovascular treatment of patients with aortic aneurysms for whom the graft seal zone requires fenestrations and involves one or more of the major visceral vessels: celiac artery, superior mesenteric artery, and/or renal arteries.
The ZFEN+ includes up to five precisely located fenestrations to accommodate the visceral vessels. This extra customization allows the graft to be tailored to the patient’s unique anatomy and maximize the seal zone to exclude the aneurysm. Cook is seeking Investigational Device Exemption (IDE) approval in the coming months with the intention of beginning a pivotal clinical study later this year.
About Cook Medical
Since 1963, Cook Medical has been inventing, manufacturing and delivering a unique portfolio of medical devices to healthcare systems around the world. We work closely with physicians to develop technologies that improve patients’ lives. Because we remain family owned, we have the freedom to focus on what we care about: patients, our employees and our communities. Find out more at CookMedical.com, and for the latest news, follow us on Twitter, Facebook and LinkedIn.
News coverage of this announcement
- Vascular News–FDA grants breakthrough device designation for Zenith fenestrated+ endovascular graft
- Vascular Specialist–FDA grants breakthrough device designation for Zenith fenestrated+ endovascular graft
- Endovascular Today–Cook Medical’s ZFen+ Endovascular Graft Receives FDA Breakthrough Device Designation
- MedTech Dive–FDA breakthrough roundup: Cook Medical is latest in round of cardio-themed nods
- Mass Device–Cook Medical wins FDA breakthrough device designation for next-gen endovascular graft
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