First implants using TREO FIT in USA and Europe announced

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This advertorial is sponsored by Terumo Aortic

Terumo Aortic
The TREO FIT system is available in the USA under PSIDE study and in Europe under a custom-made programme

On 3 October 2024, a significant milestone was achieved as Terumo Aortic announced the first implant in the world using the TREO FIT system. The procedure was performed by Benjamin W Starnes (Harborview Medical Center and the University of Washington, Seattle, USA). In the USA, TREO FIT is currently only available in the physician-sponsored investigational device exemption (PSIDE) study under Starnes’ guidance.

TREO FIT is used to facilitate physician-modified endovascular grafts (PMEGs). It guides surgeons in locating and marking fenestrations on the partially deployed TREO abdominal stent graft system to align precisely with the patient’s anatomy, reducing the need for manual measurements of fenestration locations. TREO FIT is indicated solely for use with the TREO abdominal stent graft system.

The TREO FIT system in combination with the TREO abdominal stent graft system is used in complex abdominal aortic aneurysms (AAAs), namely juxtarenal aortic aneurysms presenting with a high risk (e.g. large aneurysm size), symptomatic aneurysms and/or ruptured aneurysms. According to Terumo Aortic, this device provides an innovative solution for patients who require urgent complex AAA treatment and are unable to wait for a companymanufactured device before having surgery.

Benjamin W Starnes

Starnes, who is professor of vascular surgery at Harborview Medical Center and the University of Washington and performed the first implant of TREO FIT, commented: “As recommended through our PSIDE, I used TREO FIT for these patients due to their unique, complex anatomy and urgency. This device, currently available in our IDE, significantly simplifies the steps involved in identifying the location of fenestrations. The features of the TREO abdominal stent graft system, along with TREO FIT, optimise the performance due to the deliverability, conformability and graft design, which is suitable for creating fenestrations. The TREO stent graft has ample fabric available, ensuring that the renal fenestrations were always strut free and could be easily located on the endograft.”

A further milestone was achieved on 23 October 2024 when the first implant in Europe using the TREO FIT device took place in Bordeaux, France. The procedure was performed by Éric Ducasse (CHU Bordeaux Hospital, Bordeaux, France). In Europe, TREO FIT is currently only available through the custom-made programme.

Éric Ducasse

Following the implant, Ducasse, who is professor of vascular surgery at CHU Bordeaux Hospital, stated: “The first use of the TREO FIT platform in Europe marks a major landmark in endovascular treatment for complex abdominal aortic aneurysms. The procedure utilised a three-fenestration device to treat a fast-growing AAA. Visibility of fenestrations, target arteries, cannulation and endograft delivery were optimal. The procedure was performed in 139 minutes, including the device modification and reloading. The patient was discharged at day two with full target-vessel patency and no endoleaks. This first case validates the relevance of the TREO FIT concept and its applicability to treat emergent and semiemergent complex AAA pathologies.”

Terumo Aortic states that the importance of the first implants in the USA and Europe demonstrates a significant step forward in innovation and confirms how the TREO FIT platform, in combination with the TREO abdominal stent graft system, provides a pioneering solution for treating complex abdominal aortic aneurysms.

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