Terumo Aortic today announced the first commercial implants in the U.S. of its RelayPro thoracic stent-graft system. This follows the recent approval by the Food and Drug Administration (FDA) of a device designed to treat patients with fusiform and saccular aneurysms—as well as penetrating atherosclerotic ulcers (PAUs)—in the descending thoracic aorta.
The implants were performed by the co-national principal investigators of the pivotal RelayPro aneurysm study, Venkatesh G. Ramaiah, MD, chief of vascular and endovascular surgery at Honor Health Network in Scottsdale, Arizona and Wilson Y. Szeto, MD, chief of cardiovascular surgery at Penn Presbyterian University of Pennsylvania Health System in Philadelphia.
“The low-profile delivery system is designed to accommodate patients with smaller access vessels,” said Ramaiah. “The platform utilizes the same stent design, materials and dual-sheath technology of the proven RelayPlus system delivering the accuracy, control and confidence of RelayPlus without compromising device integrity and durability.”
Szeto added: “RelayPro is the only lower profile device with a Non-Bare Stent design available in the United States to treat aneurysms and penetrating atherosclerotic ulcers. The unique technology incorporated into the delivery system is integral to securing optimal wall apposition and allows for the effective treatment of patients with thoracic aneurysms.”
RelayPro received its CE Mark in 2017, with FDA approval announced last month.