Terumo Aortic announces FDA approval of dissection and transection indication expansion for the RelayPro stent graft

The Pro-D study was a prospective, multicentre pivotal trial conducted in 22 US centres 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.

studies suggest that overall target vessel instability and reintervention rates are favourable for self-expanding grafts as bridging stent grafts in BEVAR. Finally, however, Spanos remarked that further research in the form of randomised controlled trials may be needed in this area.

Covered stents “should be preferred” in chronic mesenteric ischaemia

The juxtarenal aortic session on bridging stents offered further salient conclusions to the CX audience, through Luke Terlouw’s (Erasmus MC University Medical Center, Rotterdam, The Netherlands) presentation of longterm results of a randomised controlled trial comparing covered with baremetal stenting of the mesenteric arteries in patients with CMI.

Terlouw described the details of the multicentre patient- and investigator-blinded trial, noting that the study included patients undergoing endovascular treatment of atherosclerotic CMI with a stenosis length of <25mm.

He defined their primary endpoint as 24-month primary patency and specified subsequent patency loss to be luminal surface area reduction ≥75% or performance of a reintervention to maintain patency. Patency was assessed by two interventional radiologists with 15 and 19 years of experience.

Presenting the conclusive findings, Terlouw confirmed that, considering the follow-up data show “significantly” better primary patency and lower reintervention rates, the covered stent should be regarded as the preferred stent when treating patients with atherosclerotic CMI.

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.” 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.

The Pro-T study was a prospective, multicentre pivotal study that enrolled 50 patients in 16 US centres. The purpose of the study was to assess the performance of RelayPro for the treatment of transection. The primary endpoint of the trial was allcause mortality at 30 days with follow-up continuing for five years.

This approval follows the results from recent studies on RelayPro dissection (RelayPro-D) and RelayPro traumatic injury (RelayPro-T).

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

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).

For the treatment of juxtarenal aortic aneurysms, reinterventions after physician-modified endovascular grafts (PMEGs) are nondetrimental to long-term survival. This is one of the main findings of a recently published study by Ayumi Tachida (University of Washington School of Medicine, Seattle, USA) and colleagues.

THE AUTHORS NOTE IN THEIR Journal of Vascular Surgery (JVS) paper that the frequency and impact of reintervention on mortality after PMEGs in unknown. It was the aim of the present study, therefore, to describe reinterventions after PMEG for the treatment of juxtarenal aneurysms and their effect on survival.

Tachida et al used 11 years’ worth of data (2011–2022) from a prospective investigational device exemption clinical trial in their study. The trial in question—officially titled ‘Physicianmodified endovascular grafts for the treatment of elective, symptomatic or ruptured juxtarenal aortic aneurysm: an investigator-initiated study’—is being led by Benjamin Starnes (University of Washington, Seattle, USA), who is also a co-author of the JVS paper.

The trial aims to enrol 300 participants with an estimated completion date of January 2035.

On the Clinical Trials webpage for the study, it is mentioned that not all patients presenting with symptomatic or ruptured aortic aneurysms are candidates for endovascular repair, with the reasons for exclusion noted to predominantly involve a lack of a suitable proximal aortic neck.

“Solutions to this problem involve multi-branched or ‘fenestrated’ endografts, which are being assessed in other clinical trials,” the study description continues. However, it is highlighted that grafts in these trials require between six and 12 weeks to manufacture and deliver to the investigational site.