Following the recent approval by the US Food and Drug Administration (FDA) of the RelayPro thoracic stent graft system for the treatment of patients with fusiform and saccular aneurysms, and penetrating atherosclerotic ulcers (PAUs) in the descending thoracic aorta, Terumo Aortic has announced the first commercial implants of this device in the USA.
The implants were performed by the co-national principal investigators of the pivotal RelayPro aneurysm study, namely, Venkatesh G Ramaiah, chief of Vascular and Endovascular
Surgery, Honor Health Network, Scottsdale, USA, and Wilson Y Szeto, chief of Cardiovascular Surgery, Penn Presbyterian University of Pennsylvania Health System, Philadelphia, USA.
Venkatesh G Ramaiah commented: “The low-profile delivery system is designed to accommodate patients with smaller access vessels. The platform utilises 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.”
Wilson Y Szeto added: “RelayPro is the only lower profile device with a non-bare stent [NBS] design available in the USA to treat aneurysms and PAUs. 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.”
Paul Kuznik, president of Terumo Aortic North America, said: “This commercial implant represents a significant milestone for the company as we embark upon delivering the most comprehensive portfolio within the aortic space.”
RelayPro received CE mark in 2017 and FDA approval in 2021.