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 accessvessels. 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 deviceintegrity 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 Stentversion; both designs offer a wide range of sizes to meet the specific anatomical needs ofpatients.
Kotaro Yoshida, General Manager at Terumo Aortic East Asia added: "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 providing a wide range of treatment options for physicians and their patients."
RelayPro received CE Mark in 2017, 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.
About Terumo Aortic
At Terumo Aortic, we partner with our customers to revolutionize aortic care. We deliver innovation, versatility and precision with the broadest range of solutions that can be personalized for every patient. We are further complementing our implantable device portfolio through the development of digital technologies.
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.