Terumo Aortic today (Friday, Aug. 6) announced that the Food and Drug Administration (FDA) has granted approval of the RelayPro thoracic stent-graft system for sale in the United States for the treatment of patients with thoracic aortic aneurysms (TAAs) and penetrating atherosclerotic ulcers (PAUs).
The FDA approval follows completion of the RelayPro aneurysm study in the U.S. and Japan, Terumo Aortic reported in a press release.
“This was a prospective, multicenter, non-blinded, non-randomized study of the RelayPro thoracic stent-graft in 110 patients with thoracic aneurysms and penetrating atherosclerotic ulcers in the descending aorta,” the release states. “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 RelayPro platform utilizes the same stent design, materials and foundational Dual Sheath Technology of the RelayPlus system, according to Terumo Aortic. Bearing a 3 to 4F reduction in outer profile, “RelayPro delivers the accuracy, control and confidence of RelayPlus without compromising device integrity and durability,” the release continues.
Co-national principal investigator (PI) of the aneurysm study, Wilson Y. Szeto, MD, chief of cardiovascular surgery at Penn Presbyterian University of Pennsylvania Health System, Philadelphia, commented: “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.”
Venkatesh G. Ramaiah, MD, co-national PI and chief of vascular and endovascular surgery at Honor Health Network, Scottsdale, Arizona, added: “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.
“In addition, the unique delivery system, the low profile and the options of Bare Stent and Non-Bare Stent are clear differentiators. This is a landmark advancement in the endovascular treatment of thoracic aneurysms.”
RelayPro received CE Mark approval in 2017.