Enrollment Begins in Bolton Medical’s Postmarket Treo Global Registry
July 25, 2017—Bolton Medical announced the first implantation of the Treo abdominal stent graft system in the Treo registry, a postmarket surveillance clinical investigation that aims to assess long-term, real-world data of the Treo technology. The registry is designed as a global, prospective, multicenter, and observational study of the Treo system in the endovascular treatment of patients with abdominal aortic aneurysms.
According to the company, the Treo system has a trimodular design with a wide range of sizes, and it allows for precise and controlled deployment with the ability to reposition the stent graft during the procedure.
Bolton Medical advised that the Treo registry is designed to capture major primary endpoints of safety and efficacy in a cohort of 600 patients recruited at up to 50 sites, and perform follow-up through 5 years to establish the long-term durability of the treatment. In addition, the Treo registry will 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.
Wouter van den Eynde, MD, performed the first implantation at the Department of Cardiovascular and Thoracic Surgery at Imelda Hospital in Bonheiden, Belgium. In the company’s press release, Dr. van den Eynde commented, “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.”
Prof. Giovanni Torsello, MD, who is the Coordinating Investigator of the registry, stated, “The Treo registry is the first initiated under the new European Medical Device Regulation and, as such, meets new stricter requirements for postmarket clinical follow-up. The aim is to set a new quality standard in the collection, reporting, and comparison of endovascular registry data.” Prof. Torsello is University Professor, Department of Vascular Surgery at St. Franziskus Hospital in Münster, Germany.
In April 2017, Bolton Medical was acquired by Vascutek Terumo following a definitive agreement announced in January.