Terumo Aortic’s RelayBranch Thoracic Stent Graft System Granted FDA Breakthrough Device Designation

March 18, 2022—Terumo Aortic announced that the FDA has granted Breakthrough Device designation for the company’s RelayBranch thoracic stent graft system, which 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, in Philadelphia, Pennsylvania, commented in Terumo Aortic’s press release, “This breakthrough designation from the FDA will allow United States 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.”

According to Terumo Aortic, the RelayBranch device is implanted in patients with thoracic aortic arch pathologies requiring treatment that includes coverage of the innominate and left common carotid arteries. The RelayBranch 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 company noted that 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 health care professionals with timely access to important breakthrough medical devices.