Michael Barbella, Managing Editor03.29.21
Cook Medical has achieved its first Breakthrough Device product.
The company's Zenith Fenestrated+ Endovascular Graft (ZFEN+) recently received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA).
“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 Breakthrough Device designation from the FDA is granted to devices that potentially can 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 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.
The company's Zenith Fenestrated+ Endovascular Graft (ZFEN+) recently received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA).
“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 Breakthrough Device designation from the FDA is granted to devices that potentially can 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 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.
