Terumo : Aortic Announces US FDA Breakthrough Device Designation for RelayBranch

March 18, 2022

Terumo Aortic today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the RelayBranch Thoracic Stent-Graft System. The RelayBranch Thoracic Stent-Graft System is implanted in patients with thoracic aortic arch pathologies requiring treatment that includes coverage of the innominate and left common carotid arteries.

The purpose of the FDA's Breakthrough Device Designation program is to fast-track the regulatory review process for certain medical technologies and device-led combination products that satisfy certain criteria; these include providing a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The aim of the program is to provide patients and healthcare professionals with timely access to important breakthrough medical devices.

The RelayBranch Thoracic Stent-Graft System consists of a main body graft which is deployed in the ascending aorta and features two anterograde tunnels that give way to a large cannulation window. Branch grafts are then deployed within these tunnels for both the innominate artery and left common carotid artery. The RelayBranch Thoracic Stent-Graft System is part of a feasibility study currently enrolling in the United States.

Wilson Szeto, MD, Chief of Cardiovascular Surgery, Penn Presbyterian University of Pennsylvania Health System, Philadelphia, commented: "This breakthrough designation from the FDA will allow US physicians to treat patients with a less invasive treatment option through the innovative technology of the RelayBranch endovascular device. This is a treatment for patients who are high risk for open surgical repair with no alternative therapies available."

Megan Indeglia, Global Vice President of Regulatory Affairs at Terumo Aortic added: "This announcement from the FDA is very encouraging and we look forward to continued collaboration with the regulatory authorities to advance treatment options for patients with complex aortic pathology."

The RelayBranch Stent-Graft System complements Terumo Aortic's innovative 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 revolutionise aortic care. We deliver
innovation, versatility and precision with the broadest range of solutions that can be
personalised for every patient. We are further complementing our implantable device
portfolio through the development of digital technologies.

Note to Editors

• Terumo acquired Vascutek Ltd. in 2002 and Bolton Medical Inc. in 2017
• Terumo Aortic has over 1,250 employees around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida

About Terumo

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 25,000 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.

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Corporate Communication Dept., Terumo Corporation

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