FDA Clears New Thoracic Aortic Aneurysm Endovascular Graft

Cook Medical has received approval from the FDA for its Zenith TX2 Thoracic TAA Endovascular Graft, marking the expansion of Cook Medical’s portfolio of devices to treat aortic diseases.

The Zenith TX2 endograft system is designed for thoracic endovascular aortic repair (TEVAR). The endograft is indicated to treat patients with aneurysms or ulcers of the descending thoracic aorta that have vascular morphology suitable for endovascular repair. With FDA approval of the Zenith TX2, U.S. physicians can now provide an endovascular solution from Cook for the interventional treatment of thoracic aortic aneurysms (TAA), including patients who may not be eligible for treatment through open surgery.