Cook Medical gets FDA nod for endovascular graft trial for treating aortic aneurysm

The Zenith Fenestrated AAA Endovascular Graft. [Image from the Cook Medical website]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 3…

Read more
  • 0