Enrollment Completed in Pivotal Study of Terumo Aortic’s Relay Pro for Treatment of Traumatic Thoracic Injury

January 26, 2021—Terumo Aortic announced the completion of enrollment of the Relay Pro traumatic injury pivotal study (Relay Pro-T). The Relay Pro-T study has enrolled 50 patients with traumatic injury of the descending thoracic aorta at 16 sites across the United States.

Terumo Aortic’s Relay Pro device is a low-profile, next-generation thoracic stent graft device designed to expand the treatment of thoracic endovascular aortic repair to patients with smaller access vessels.

According to the company, the Relay Pro-T study is conducted under an investigational device exemption in the United States. The purpose of this prospective, multicenter, nonblinded, nonrandomized study is to analyze endovascular repair of traumatic aortic injury, or transection, usually caused by high-speed impacts such as those in road traffic accidents or serious falls. The primary endpoint of the trial is all-cause mortality at 30 days, with follow-up continuing for 5 years.

The study’s Co-National Principal Investigators are Benjamin W. Starnes, MD, and Ravi Rajani, MD.

In Terumo Aortic’s press release, Dr. Starnes commented, “This is an important landmark in moving this device along the regulatory pathway and making it available to surgeons throughout the United States to treat these emergency cases. The Relay device has already shown outstanding navigability, total accuracy, and less risk of air embolism thanks to its unique dual-sheath design. In addition, the low profile of the Relay Pro device will make it suitable for more patients.”

Dr. Rajani added, “The endovascular management of traumatic aortic injury has the potential advantages of less morbidity due to smaller incisions as well as shorter operating times. A device that can further improve on these advantages with a lower profile and a more flexible delivery system will be a welcome addition to our treatment options. Greater spacing between stent zones makes it more conformable to the aortic wall, even in the highly angled aortic arch of the typically young trauma patient.”

Dr. Starnes is Professor of Vascular Surgery, Chief of Division of Vascular Surgery, and Vice Chair of Department of Surgery at the University of Washington in Seattle, Washington. Dr. Rajani is Associate Professor of Vascular Surgery at Emory University School of Medicine and Chief of Vascular and Endovascular Surgery at Grady Memorial Hospital in Atlanta, Georgia.