Cook Medical announced that it enrolled the final patient in the global clinical study of its Zenith Fenestrated+ Endovascular Graft (ZFEN+).
ZFEN+ won FDA investigational device exemption (IDE) in June 2023. This study, conducted under that IDE, assesses ZFEN+’s safety and effectiveness used in combination with the investigational Zenith unviersal distal body 2.0 graft (Unibody2), the investigational Bentley BeGraft balloon-expandable FEVAR bridging stent graft system (BeGraft) and the commercially available Zenith Spiral-Z AAA iliac leg graft (ZSLE).
Bloomington, Indiana-based Cook Medical says the milestone signifies the completion of patient recruitment in its pivotal study.
ZFEN+, predicated on the commercially available ZFEN AAA endovascular graft, extends the proximal margin of treatable aneurysmal disease. It includes patients with more complex aortic disease involving one or more of the major visceral arteries.
The endovascular graft includes up to five precisely located fenestrations to accommodate visceral vessels. It can also include a combination not to exceed a total of five made up of fenestrations and one scallop. Physicians can order fenestrations and scallops specifically to match the patient’s unique anatomy.
Cook Medical says ZFEN+ enables the endovascular treatment of patients with aortic aneurysms and maximizes the seal zone to exclude the aneurysm.
“Now that enrollment is complete, we are one step closer to understanding the outcomes of patients treated with ZFEN+ and, ultimately, to advancing care for patients with complex abdominal and thoracoabdominal aneurysms,” said Johnny LeBlanc, director, product management, Aortic at Cook Medical. “Reaching this milestone is a direct reflection of the dedication shown by our investigator partners, study coordinators, and—most importantly—the patients who supported the study with their time and trust. We look forward to analyzing the data and sharing the results with the clinical community.”
