Cook Medical has announced the first patient treated in the clinical study of the ZENITH FENESTRATED+ endovascular graft (ZFEN+) in the USA. The procedure was performed on January 29, 2024 at The University of Texas Health (UTHealth) in Houston, Texas, by Gustavo Oderich, global principal investigator.
“We are ecstatic at UTHealth Houston to have treated this first ZFEN+ patient. This is a huge step forward in getting the first patient-specific device for complex abdominal and extent IV thoracoabdominal aneurysms with fenestrations. Rather than a one-size-fits-all approach, the ZFEN+ device design aims to optimise patient needs,” said Oderich.
The ZFEN+ clinical study is being conducted under an investigational device exemption (IDE) from the US Food and Drug Administration (FDA). 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 fenestrated endovascular aortic repair (FEVAR) bridging stent graft system and the commercially available Zenith Spiral-Z abdominal aortic aneurysm (AAA) Iliac leg graft (ZSLE).
The ZFEN+ clinical study will enrol patients in need of treatment of aortic aneurysms involving one or more of the major visceral arteries. Patients with juxtarenal, pararenal and extent IV thoracoabdominal aneurysms meeting specific anatomical requirements may be included in the study. The ZFEN+ device is designed with fenestrations aligned to a patient’s unique anatomy and to extend the proximal margin of aneurysmal disease that can be treated endovascularly.
“On behalf of Cook Medical, we are very excited to announce the first implant of ZFEN+. This is an exciting milestone in the advancement of fenestrated aortic technology. This next generation of patient-specific aortic endograft technology has received a breakthrough device designation from the FDA. This advancement will enable physicians to select up to five target vessels. Our team is committed to listening, collaborating and bringing these innovative technologies to a broader patient population,” said Johnny LeBlanc, director of aortic product management at Cook Medical.
