September 25, 2019
Terumo Aortic Completes Enrollment of RelayPro United States Pivotal Trial
September 26, 2019—Terumo Aortic announced the completion of enrollment of the RelayPro pivotal trial in the United States. RelayPro is a low-profile, next-generation thoracic stent graft device designed for the treatment of thoracic endovascular aortic repair (TEVAR) in patients with smaller access vessels. The device has CE Mark approval and was launched in Europe in 2018.
According to Terumo Aortic, the RelayPro aneurysm study is a prospective, multicenter, nonblinded, nonrandomized evaluation of the RelayPro thoracic stent graft in patients with thoracic aortic aneurysms and penetrating atherosclerotic ulcers. The primary endpoint for safety is a composite of major adverse events, and the primary endpoint for effectiveness is a composite of technical and clinical success. This trial will include bare stent and nonbare stent configurations of RelayPro. The study has enrolled 110 patients across sites in the United States and Japan.
The RelayPro device utilizes the same stent design, material, and dual-sheath technology as the company’s RelayPlus device, with the additional benefit of a 3-F to 4-F reduction in the outer profile, noted Terumo Aortic.
The study’s Coprincipal Investigator Wilson Szeto, MD, commented in Terumo Aortic’s announcement, “RelayPro’s ability to land accurately combined with its low profile will allow me to successfully treat complex anatomy with precision.”
Coprincipal Investigator Venkatesh Ramaiah, MD, added, “One of the key benefits of RelayPro is being able to choose from a range of proximal configurations, allowing me to tailor my device selection to meet the individual needs of each patient.”