Cook Zenith Fenestrated+ Endovascular Graft Pivotal Study Completes Enrollment

August 28, 2025—Cook Medical announced that the final patient has been enrolled in the global clinical study of the company’s investigational Zenith Fenestrated+ endovascular graft (ZFen+), marking completion of recruitment in the pivotal study.

According to the company, the ZFEN+ clinical study of fenestrated endovascular aneurysm repair (FEVAR) of abdominal aortic aneurysms (AAAs) is being conducted under an FDA investigational device exemption and with authorization for a clinical investigation under the United Kingdom’s Medicines and Healthcare Products Regulatory Agency.

Cook stated that the study is assessing the safety and effectiveness of the ZFen+ device used in combination with the company’s investigational Zenith universal distal body 2.0 graft (Unibody2), Bentley’s investigational BeGraft balloon-expandable FEVAR bridging stent graft system, and Cook’s commercially available Zenith Spiral-Z AAA iliac leg graft (ZSLE).

As noted in the press release, the ZFen+ is predicated on Cook’s commercially available ZFen AAA endovascular graft but extends the proximal margin of aneurysmal disease that can be treated endovascularly to include patients with more complex aortic disease involving one or more of the major visceral arteries.

The ZFen+ graft, which was granted FDA Breakthrough Device designation in 2021, allows for the endovascular treatment of patients with aortic aneurysms and maximizes the seal zone to exclude the aneurysm, stated Cook Medical.

In January 2024, Cook Medical announced enrollment of the first patient  in the United States in the trial. The procedure was performed by Global Principal Investigator Gustavo Oderich, MD.

“Amazing work from the clinical research team on the enrollment of the final ZFEN+ patient,” commented Dr. Oderich in the current press release. “The clock is now ticking for us to have a patient-specific solution for complex aortic aneurysms that will optimize seal without compromise.”