Terumo Aortic’s RelayPro thoracic stent-graft system has gained FDA approval for treatment of thoracic aortic aneurysms and penetrating atherosclerotic ulcers.

RelayPro, which is designed to expand thoracic endovascular aortic repair to patients with smaller access vessels, received a CE mark certification in 2017.

The UK-based company says the FDA approval followed the successful completion of a study of the device in 110 U.S. and Japanese patients.