Terumo Aortic announced that the Food and Drug Administration (FDA) has granted approval of the RelayPro thoracic stent graft device for the treatment of dissection and transection in the U.S.
A Terumo Aortic press release notes that RelayPro delivers uncompromised clinical performance in the lowest commercially available profile and is indicated for all pathologies of the descending thoracic artery; aneurysm, penetrating atherosclerotic ulcers, transection and dissection. RelayPro offers unparalleled accuracy, proven efficacy and durability as well as the widest range of sizes, tapering and configurations on the market, designed to expand the treatment of thoracic endovascular aortic repair (TEVAR) to patients with smaller access vessels, the release continues.
This approval follows the results from recent studies on RelayPro Dissection (RelayPro-D) and RelayPro traumatic injury (RelayPro-T).
The Pro-D study was a prospective, multicenter pivotal trial conducted in 22 U.S. centers and enrolled 56 patients with acute, complicated type B aortic dissection. Approximately two thirds of the subjects 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 five years.
National principal investigator of the Pro-D study, Peter Rossi (Medical College of Wisconsin, Milwaukee, USA), said: “The fully covered, non-bare stent (NBS) 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. I am very encouraged by the one-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.”
The Pro-T study was a prospective, multicenter pivotal study that enrolled 50 patients in 16 U.S. centers. The purpose of the study was to assess the performance of RelayPro for the treatment of transection. The primary endpoint of the trial was all-cause mortality at 30 days was 2% with follow-up continuing for five years.
National principal investigator of the Pro-T study, Benjamin W. Starnes (University of Washington, Seattle, USA) commented: “We are 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 per cent of the procedures in this study were percutaneous, highlighting a distinct value of the RelayPro stent graft system.” The approval of RelayPro-T also introduces a 22mm diameter option.
The RelayPro thoracic stent graft received CE mark approval in 2017 and FDA approval in 2021 for the treatment of patients with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAUs).