Cook Medical’s ZFen+ Endovascular Graft Receives FDA Breakthrough Device Designation

March 1, 2021—Cook Medical announced that the FDA has granted Breakthrough Device designation for the company’s Zenith fenestrated+ (ZFen+) endovascular graft. The ZFen+ is the first product from Cook Medical to receive a Breakthrough Device designation, noted the company. Cook is seeking approval for an investigational device exemption in the coming months with the intention of beginning a pivotal clinical study later in 2021.

The company noted that 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. 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.

According to Cook Medical, the ZFen+ is built on the company’s Zenith platform and represents the next generation of our Zenith fenestrated abdominal aortic aneurysm (AAA) endovascular graft. The device 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, stated the company.