Terumo Aortic today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval of the RelayPro Thoracic Stent-Graft System for sale in Japan for the treatment of patients with thoracic aortic aneurysms (TAA).
RelayPro is a low profile, next generation thoracic stent-graft device designed to expand the treatment of thoracic endovascular aortic repair (TEVAR) to patients with smaller access
vessels. The platform utilises the same stent design, materials and foundational Dual Sheath Technology of the proven RelayPlus system; with a 3 to 4 Fr reduction in outer profile, RelayPro delivers the accuracy, control and confidence of RelayPlus without compromising device
integrity and durability. RelayPro is available in Japan with a Non-Bare Stent (NBS) design to treat thoracic aortic aneurysms. This configuration is further complemented by a Bare Stent
version; both designs offer a wide range of sizes to meet the specific anatomical needs of
Kotaro Yoshida, General Manager at Terumo Aortic East Asia commented: “We are confident that we will contribute to expanding thoracic aortic endovascular stent graft treatment in Japan through this approval. We will strive to continue improving the quality of products, supplies and services in the aortic area, and provide a wide range of treatment options for physicians and their patients.”
RelayPro received CE Mark approval in 2017 and FDA approval in 2021; it is integral to Terumo Aortic’s market leading portfolio of surgical, endovascular and hybrid devices to treat every
segment of the aorta.