Early Feasibility Study Begins for Terumo Aortic's RelayBranch Thoracic Stent Graft System

April 30, 2018—Terumo Aortic announced the commencement of the RelayBranch Early Feasibility Study. The trial will assess the safety and efficacy of the company's RelayBranch thoracic stent graft system in patients with thoracic aortic pathologies requiring treatment proximal to the origin of the innominate artery.

The first two patients enrolled in the trial were treated by Luis Sanchez, MD, Chief of the Section of Vascular Surgery, and Marc Moon, MD, Chief of the Section of Cardiac Surgery, Washington University in St. Louis—Barnes Jewish Hospital in St. Louis, Missouri.

In Terumo Aortic's announcement, Dr. Sanchez commented, “RelayBranch expands the range of endovascular treatment options for a high-risk population. We are very pleased to be able to offer an endovascular alternative to our patients.” Dr. Moon will present the details of the cases on May 1 at the 98th annual meeting of the American Academy for Thoracic Surgery held April 28 to May 1 in San Diego, California.

According to the company, the RelayBranch thoracic stent graft system establishes an endovascular alternative for patients requiring the standard surgical approach of median sternotomy to treat patients with aortic arch pathology. The company noted that with sternotomy, the distal aspect of the arch and proximal descending thoracic aorta are difficult to expose and pose an additional risk to the patient.

Terumo Aortic stated that 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 tunnels have lock stents that were designed to provide a secure engagement with the branch grafts and prevent modular disconnection. The main body also incorporates Terumo Aortic's nonbare stent technology, which features a fully covered proximal end that is clasped to the delivery system to enable accurate deployment. Additionally, the RelayBranch system uses the company's low-profile, next-generation RelayPro delivery system, which is currently under clinical trial in the United States.