Endovascular graft trial gets FDA approval

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 of Bentley. MassDevice