Following the recent approval by the US Food and Drug Administration (FDA) of the Relay®Pro 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 announced today the first commercial implants of this device in the United States.
The implants were performed by the Co-National Principal Investigators of the pivotal RelayPro aneurysm study, namely, Venkatesh G Ramaiah MD, Chief of Vascular and Endovascular Surgery, Honor Health Network, Scottsdale, Arizona, US, and Wilson Y Szeto MD, Chief of Cardiovascular Surgery, Penn Presbyterian University of Pennsylvania Health System, Philadelphia, US.
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 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.”
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; it is integral to Terumo Aortic’s market leading portfolio of surgical, endovascular and hybrid devices to treat every segment of the aorta.