Terumo Aortic’s RelayPro Approved by FDA for Dissection and Transection

May 5, 2023—Terumo Aortic announced that the FDA has granted approval of the RelayPro thoracic stent graft for the treatment of dissection and transection.

According to the company, the RelayPro device is indicated for all pathologies of the descending thoracic artery: aneurysm, penetrating atherosclerotic ulcers, transection, and dissection.

The device is offered in a wide range of sizes, tapering, and configurations. It is designed to expand the treatment of thoracic endovascular aortic repair (TEVAR) to patients with smaller access vessels. The approval of RelayPro for transection also introduces a 22-mm diameter option, noted the company.

The company noted that this approval comes after results from recent studies on RelayPro dissection (Relay Pro-D) and RelayPro traumatic injury (Relay Pro-T).

The prospective, multicenter, Pro-D pivotal trial was conducted in 22 centers in the United States and enrolled 56 patients with acute, complicated type B aortic dissection. Approximately two-thirds of the patients in the study had dissection extension to the iliac arteries. The primary endpoint of all-cause mortality at 30 days was 1.8% and demonstrated a clear early survival benefit. Patients will be followed for 5 years.

Peter Rossi, MD, national principal investigator of the Pro-D study, commented in the company’s press release, “The fully covered, nonbare stent configuration of RelayPro was most used in the pivotal trial, highlighting the clinical value of this platform, and a full 86% of procedures were percutaneous.”

Dr. Rossi continued, “I am very encouraged by the 1-year outcomes of this pivotal study, which will be published soon, now that approval of this new-generation device has been granted. Also, it is heartening that our dissection patients will have this additional option.” Dr. Rossi is Professor and Chief of the Division of Vascular and Endovascular Surgery at the Medical College of Wisconsin in Milwaukee, Wisconsin.

The Pro-T study was conducted to assess the performance of RelayPro for the treatment of transection. The prospective, multicenter pivotal study enrolled 50 patients in 16 United States centers. The primary endpoint of all-cause mortality at 30 days was 2% with follow-up continuing for 5 years.

The national principal investigator of the Pro-T study is Benjamin W. Starnes, MD, who commented in the press release, “We’re looking forward to having this latest generation device available for all thoracic indications. A low-profile device will be particularly useful for trauma patients who are typically younger and with smaller access vessels. Eighty percent of the procedures in this study were percutaneous, highlighting a distinct value of the RelayPro stent-graft system.” Dr. Starnes is Professor and Chief of Vascular Surgery at the University of Washington in Seattle, Washington.

The company also advised that with the RelayPro “Upon Request” program, which was launched in January 2022, there are approximately 2,000 stent-graft configurations approved by the FDA. This comprehensive portfolio allows physicians the versatility to select devices that best fit the anatomic needs of each individual patient.

The RelayPro thoracic stent graft received CE Mark approval in 2017 and FDA approval was announced in 2021 for the treatment of patients with thoracic aortic aneurysms and penetrating atherosclerotic ulcers.