CAUTION – INVESTIGATIONAL DEVICE. Limited by United States law to investigational use.
Bloomington, Ind. — Cook Medical has enrolled the final patient in the global clinical study of the ZENITH® FENESTRATED+ Endovascular Graft (ZFEN+). This milestone signifies the completion of patient recruitment in the pivotal study and demonstrates Cook’s commitment to innovating medical devices for the treatment of aortic diseases.
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). This clinical study will assess the safety and effectiveness of the 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, 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 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+ is an endovascular graft which includes up to 5 precisely located fenestrations, or a combination not to exceed a total of 5 made up of fenestrations and 1 scallop (cut-outs from the proximal margin of the endograft material) to accommodate visceral vessels. Physicians can order fenestrations and scallops specifically to match the patient’s unique anatomy. Overall, the ZFEN+ allows for the endovascular treatment of patients with aortic aneurysms and maximizes the seal zone to exclude the aneurysm. The product was granted Breakthrough Designation from the FDA in 2021.
“Reaching full enrollment in this important clinical study is a major milestone for Bentley and a significant step toward making our BeGraft Bridging stent available to patients in the United States. It underscores the strength of our collaboration with Cook Medical and reflects our shared commitment to advancing innovative vascular solutions that improve patient outcomes,” said Sebastian Büchert, Bentley CEO.
“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,” said Dr. Gustavo Oderich, the global principal investigator of the clinical study.
Additional information about the clinical study will be available at www.clinicaltrials.gov.
