Following the recent publication in the Journal of Vascular Surgery, Terumo Aortic announced today the mid-term results from the Relay®Plus post approval study (PAS).
The Relay®Plus thoracic stent graft system is approved by the US Food and Drug Administration (FDA) to treat patients with thoracic aortic disease. The purpose of this multicentre, non-randomised, prospective study undertaken in the United States with novice implanters, was to report real-world outcomes of patients with thoracic aortic aneurysms and penetrating atherosclerotic ulcers (PAUs) undergoing thoracic endovascular aortic repair (TEVAR).
Over a three-year period, the Relay®Plus stent graft was implanted in a total of 45 patients. Results showed 95.6% freedom from TEVAR-related mortality, 84.0% freedom from all-cause mortality, and 97.2% freedom from reinterventions. Only centres with no previous experience with this stent graft participated in the post approval study and confirmed 100% technical success and sustained freedom from TEVAR-related mortality in the mid-term. 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 lead author of the study, Mahmoud Malas, MD, (Chief of Vascular and Endovascular Surgery and Vice Chair of Surgery for Clinical Research at the University of California, San Diego) commented: “The Relay®Plus 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 mid-term follow-up of the study.”
The longer-term sustainability of these clinical outcomes with Relay®Plus stent graft will be determined through 5 years of follow-up.