Terumo Aortic has announced that the US Food and Drug Administration (FDA) has granted approval of its RelayPro thoracic stent-graft system for sale in the USA for the treatment of patients with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAUs).
The approval follows the successful completion of the RelayPro aneurysm study in the United States and Japan. This was a prospective, multi-centre, non-blinded, non-randomised study of the RelayPro thoracic stent-graft in 110 patients with thoracic aneurysms and PAUs in the descending aorta.
RelayPro is a low profile, next generation thoracic stent-graft device designed to expand the treatment of thoracic endovascular aortic repair (TEVAR) to patients with smaller access vessels.
The platform utilises the same stent design, materials and foundational Dual Sheath Technology of the RelayPlus system; with a three to four French reduction in outer profile, RelayPro delivers the accuracy, control and confidence of RelayPlus without compromising device integrity and durability, say Terumo Aortic.
Wilson Szeto, chief of cardiovascular surgery at Penn Presbyterian University of Pennsylvania Health System (Philadelphia, USA), and co-national principal investigator of the study: said: “RelayPro’s ability to navigate smoothly over the arch as a result of the Dual Sheath system enables accurate deployment, and combined with the low profile of the device, this allows me to successfully treat complex anatomy with precision.”
A company press release also states that the 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.
Paul Kuznik, president of Terumo Aortic North America, added: “Today’s announcement represents a significant opportunity for Terumo Aortic in the United States further complementing our abdominal endovascular and open surgical graft portfolio, as well as expanding our range of products to treat thoracic aortic aneurysms. We are committed to providing physicians with innovative aortic solutions for the treatment of their patients.”
“One of the key features and benefits of RelayPro is being able to choose from a range of sizes and tapers, allowing me to tailor my device selection to meet the individual needs of each patient and adapt to complex anatomy and morphology,” said co-National principal investigator Venkatesh G Ramaiah (chief of Vascular and Endovascular Surgery Honor Health Network, Scottsdale, USA) “In addition, the unique delivery system, the low profile, and the options of bare stent and nonbare stent are clear differentiators. This is a landmark advancement in the endovascular treatment of thoracic aneurysms.”