Terumo Aortic has 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 (TAAs).
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 company notes.
The platform utilises the same stent design, materials and foundational dual-sheath technology of the proven RelayPlus system. According to Terumo Aortic, RelayPro delivers the accuracy, control and confidence of RelayPlus without compromising device integrity and durability, with a 3 to 4Fr reduction in outer profile.
RelayPro is available in Japan with a non-bare stent (NBS) design to treat TAAs. 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 patients.
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 US Food and Drug Administration (FDA) approval in 2021.