Cook Receives FDA Approval for Endovascular Graft

The FDA has approved Cook Medical’s Zenith TX2 thoracic TAA endovascular graft.

The aortic endograft is used for thoracic endovascular aortic repair (TEVAR), a minimally invasive alternative to traditional, open surgery. The device is indicated to treat patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair.

Results from the STARZ-TX2 clinical trial indicated that the TEVAR procedure with the product is a safe and effective alternative to open surgical repair, according to Cook.