Terumo Aortic has announced the midterm results from the RelayPlus thoracic stent graft system post-approval study, revealing low operative mortality and morbidity— supporting its use as a “safe and effective” thoracic aortic aneurysm treatment.
Over a three-year period, the RelayPlus stent graft was implanted in a total of 45 patients and showed 95.6% freedom from thoracic endovascular aortic repair (TEVAR)-related mortality, 84% freedom from all-cause mortality, and 97.2% freedom from reintervention. The results were published in the Journal of Vascular Surgery (JVS) in June.
The purpose of the multicenter, nonrandomized, prospective study was to report real-world outcomes of patients with thoracic aortic aneurysms and penetrating atherosclerotic ulcers undergoing TEVAR.
Only centers with no previous experience with the stent graft participated in the post-approval study, confirming 100% technical success and sustained freedom from TEVAR-related mortality in the midterm.
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, according to Terumo.
“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,” commented lead author of the study, Mahmoud Malas, MD, chief of vascular and endovascular surgery as well as vice chair of surgery for clinical research at the University of California, San Diego. “These results show a durable thoracic endovascular treatment at the midterm follow-up of the study.”
The longer-term sustainability of these clinical outcomes with RelayPlus stent graft—approved by the Food and Drug Administration (FDA) in 2012—will be determined through 5 years of follow-up.
Writing in JVS, Malas et al concluded: “The RelayPlus post-approval study reported low operative mortality and morbidity and supported use of the device as a safe and effective thoracic aortic aneurysm and [penetrating atherosclerotic ulcer] endovascular treatment. Early midterm follow-up showed sustained freedom from TEVAR-related mortality in real-world practice. Follow-up continues to evaluate the durability of this endograft.”