Recruitment Ends for ZENITH  FENESTRATED+ Endovascular Graft Study

Cook Medical has enrolled the final patient in a global clinical study of its ZENITH  FENESTRATED+ Endovascular Graft  (ZFEN+).

The investigational ZFEN+ clinical study is being conducted under an Investigational Device Exemption (IDE) approved by the U.S. Food and Drug Administration (FDA) and with authorization for a clinical investigation under Medicines and Healthcare products Regulatory Agency (MHRA). The trial will assess the safety and effectiveness of ZFEN+ used in combination with the investigational Zenith Universal 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). 

“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 of 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.” 

The ZFEN+ is predicated on the commercially available Zenith Fenestrated (ZFEN) AAA Endovascular Graft but extends the proximal aneurysmal disease margin that can be treated endovascularly to include patients with more complex aortic disease involving one or more of the major visceral arteries. The ZFEN+ is an endovascular graft that includes up to five precisely located fenestrations, or a combination not to exceed five comprised of fenestrations and one scallop (cut-outs from the endograft material’s proximal margin) to accommodate visceral vessels. Physicians can order fenestrations and scallops specifically to match the patient’s unique anatomy. Overall, the ZFEN+ provides endovascular treatment for patients with aortic aneurysms and maximizes the seal zone to exclude the aneurysm. The product was granted FDA Breakthrough Designation in 2021. 

“Reaching full enrollment in this study is a major milestone for Bentley and a significant step toward making our BeGraft Bridging stent available to patients in the United States,” Bentley CEO Sebastian Büchert stated. “It underscores the strength of our collaboration with Cook Medical and reflects our shared commitment to advancing innovative vascular solutions that improve patient outcomes.”   

“Amazing work from the clinical research team on the enrollment of the final ZFEN+ patient. The clock is now ticking for us to have a patient specific solution for complex aortic aneurysms that will optimize seal without compromise,” commented Dr. Gustavo Oderich, the study’s global principal investigator.  

Cook Medical is headquartered in Bloomington, Ind., and maintains manufacturing facilities and offices in various global locations.