Bolton Medical has announced the first implant of the Treo abdominal stent graft system in the Treo Registry, a post-market surveillance clinical investigation that aims to assess long term real-world data of the device in a global, prospective, multicentre and observational study.
The Treo abdominal stent-graft system designed to optimise the endovascular treatment of patients with abdominal aortic aneurysms. It has a tri-modular design with a wide range of sizes, and it is intended to allow for precise and controlled deployment with the ability to reposition the stent-graft during the procedure.
The first implant was performed in the Department of Cardiovascular and Thoracic Surgery at Imelda Hospital, Bonheiden, Belgium, by Wouter van den Eynde, who notes, “Treo performed nicely with precision and control during the deployment. The release of the proximal stent and removal of the system was intuitive and gave me confidence. The device is designed to avoid snagging during removal and the leave-behind sheath simplifies the procedure avoiding multiple access entries”.
The Treo registry is designed to capture major primary endpoints of safety and efficacy in a cohort of 600 patients recruited in up to 50 sites and perform follow-up through five years to establish the long-term durability of the treatment.
Another aspect of the Treo registry is to capture real-world clinical practice data in a variety of hospital settings on the treatment of abdominal disease. The study will have external image review and electronic data capturing to validate data.
Giovanni Torsello, Munster, Germany, coordinating Investigator of the registry, highlights, “The Treo Registry is the first initiated under the new European Medical Device Regulation and, as such, meets new stricter requirements for post-market clinical follow-up. The aim is to set a new quality standard in the collection, reporting and comparison of endovascular registry data.”