Terumo Aortic announced today the completion of enrolment of the Relay®Pro Traumatic Injury
(Relay®Pro–T) Investigational Device Exemption (IDE) study in the United States. Relay®Pro 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 access vessels.
The Relay®Pro-T study has successfully enrolled a total of 50 patients with traumatic injury of the descending thoracic aorta at 16 sites across the United States.
The purpose of this prospective, multicentre, non-blinded, non-randomised study is to analyse 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 five years.
Co-National Principal Investigator, Benjamin W Starnes, MD, (Professor of Vascular Surgery, Chief of Division of Vascular Surgery and Vice Chair of Department of Surgery, University of Washington, Seattle, US) 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.”
Furthermore, co-National Principal Investigator, Ravi Rajani, MD, (Associate Professor of Vascular Surgery, Emory University School of Medicine and Chief of Vascular and Endovascular Surgery, Grady Memorial Hospital, Atlanta, US) 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.”