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 RelayPlus 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 RelayPlus 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 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 mid-term follow-up of the study."
The longer-term sustainability of these clinical outcomes with RelayPlus stent graft will be determined through 5 years of follow-up.
About Terumo Aortic
At Terumo Aortic, our vision is the continued development of innovative and unique products to facilitate the evolution of new surgical, hybrid and endovascular techniques, integrating custom solutions to treat complex aortic pathologies, and deliver the most comprehensive device portfolio in the aortic space. We are further complementing our implantable device portfolio through the development of digital technologies delivering apps and value-added services featuring analysis, diagnosis, treatment and post-operative care.
Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 28,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.