Midterm Results Published From Postapproval Study of Terumo Aortic’s RelayPlus TEVAR System

December 7, 2020—Terumo Aortic announced that midterm results from the postapproval study of its RelayPlus thoracic stent graft system were published by Mahmoud Malas, MD, et al online ahead of print in Journal of Vascular Surgery (JVS). As noted in JVS, the study’s purpose was to report real-world outcomes of patients with thoracic aortic aneurysms and penetrating atherosclerotic ulcers who are undergoing thoracic endovascular aortic repair (TEVAR) with RelayPlus.

Terumo Aortic noted that the RelayPlus stent graft, which received FDA approval in 2012, was implanted in a total of 45 patients over a 3-year period. Only centers with no previous experience with the RelayPlus participated in the postapproval study, and they confirmed 100% technical success and sustained freedom from TEVAR-related mortality in the midterm results.

According to the company, the study demonstrated the following:

• Freedom from TEVAR-related mortality of 95.6%
• Freedom from all-cause mortality of 84%
• Freedom from reinterventions of 97.2%

Terumo Aortic stated that these results mirror what was seen in the pivotal study, demonstrating the ease of use and high degree of clinical success in real-world patients. The company advised that the longer-term sustainability of these clinical outcomes will be determined through 5 years of follow-up.

Dr. Malas commented in the company’s announcement, “The RelayPlus system introduced a number of design improvements and innovations that facilitate the procedure for the physician; the questions were whether these elements could result in better clinical outcomes for the patient and whether those advantages persisted in the longer term. These results show a durable thoracic endovascular treatment at the midterm follow-up of the study.” Dr. Malas is Chief of Vascular and Endovascular Surgery and Vice Chair of Surgery for Clinical Research at the University of California, San Diego, in San Diego, California.