Cook Medical received FDA approval to initiate an investigational device exemption (IDE) study for an aortic aneurysm treatment.
The study will evaluate the Zenith Fenestrated + Endovascular Graft (ZFEN+). It assesses the safety and effectiveness of ZFEN+ in combination with Bentley’s InnoMed BeGraft balloon-expandable Fevar bridging stent graft system. The companies aim to look at the treatment of aortic aneurysms involving one or more of the major visceral arteries.
ZFEN+ remains predicated on the commercially available Zenith Fenestrated AAA Endovascular Graft. However, it extends the proximal margin of aneurysmal disease for endovascular treatment. This includes patients with more complex aortic disease. Currently, only open surgical repair stands as an option for treating complex aortic disease, Cook Medical said.
“Outside the United States, Bentley has supplied 300,000 BeGraft stents to patients in 80 countries around the world. We are pleased that this study approval of the FDA brings us one step closer to making our leading technology also available to American patients suffering from vascular diseases,” said Sebastian Büchert, CEO, Bentley.
About the Cook Medical study
The prospective, multicenter, single-arm study includes sites in the U.S. and Europe. At present, FDA approved the enrollment of the first 30 patients. Cook Medical ultimately intends to enroll 102 patients in the pivotal study. The study has a primary safety endpoint of the composite measure of device technical success and procedural safety within 30 days.
Cook Medical set a primary effectiveness endpoint of a composite measure of freedom from aneurysm-related mortality and freedom from clinically significant reintervention through 12 months post-procedure.
“The clinical community has been asking for a durable, low-profile commercial device that allows them to easily treat more patients. We pioneered this technology with key thought leaders and continue to listen and innovate to the market needs. The ZFEN+ has received breakthrough device designation from the FDA, so we’re excited to see this innovation progress into a clinical study. The ZFEN+ is the next generation and future of fenestrated technologies,” said Johnny LeBlanc, director of aortic product management, Cook Medical.