Cook Medical has enrolled the final patient in the global clinical study of its Zenith Fenestrated+ endovascular graft (ZFEN+), signifying completion of patient recruitment in the pivotal study.
The investigational ZFEN+ clinical study is being conducted under an Investigational Device Exemption (IDE) approved by the US Food and Drug Administration (FDA) and with authorisation for a clinical investigation under Medicines and Healthcare products Regulatory Agency (MHRA), the company states in a press release.
The 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), Bentley‘s investigational BeGraft balloon-expandable fenestrated endovascular aneurysm repair (FEVAR) bridging stent graft system and Cook’s commercially available Zenith Spiral-Z abdominal aortic aneurysm (AAA) iliac geg graft (ZSLE).
Cook shares that 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 five precisely located fenestrations, or a combination not to exceed a total of five made up of fenestrations and one 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 company states, the ZFEN+ allows for the endovascular treatment of patients with aortic aneurysms and maximises the seal zone to exclude the aneurysm. The product was granted Breakthrough Designation from the FDA in 2021.
“Amazing work from the clinical research team on the enrolment of the final ZFEN+ patient. The clock is now ticking for us to have a patient-specific solution for complex aortic aneurysms that will optimise seal without compromise,” said Gustavo Oderich (Baylor College of Medicine and Texas Heart Institute, Houston, USA), the global principal investigator of the clinical study.
