Terumo Aortic and Bentley today announced their partnership in a clinical study in the USA. The objective is to obtain US Food and Drug Administration (FDA) investigational device exemption (IDE) approval for Terumo Aortic’s fenestrated Treo device, in combination with Bentley’s BeFlared fenestrated endovascular aneurysm repair (FEVAR) stent graft system for FEVAR procedures. The IDE submission is planned for the first half of 2026.
Through this collaboration, Terumo Aortic and Bentley note in a press release that they aim to bring their FEVAR solutions to benefit US patients suffering from complex abdominal aortic aneurysms, namely juxtarenal and suprarenal aneurysms. Following the completion of the joint clinical study and FDA approval, both companies plan to independently market their products in the USA.
Terumo Aortic shares that its fenestrated Treo device offers a patient-specific solution tailored to the anatomical conditions and clinical needs for treating aortic aneurysms. The company details that, to ensure perfusion of vital organs, the device can be designed to include up to five fenestrations, requiring reliable bridging stents to maintain
perfusion to the target vessels.
Erik Pomp, chief executive officer (CEO) of Terumo Aortic, commented: “Bentley’s BeFlared, the world’s first-to-market dedicated bridging stent, is a great fit for our fenestrated Treo platform. With its innovative features, this stent has the potential to become the gold standard in FEVAR procedures, thus complementing our fenestrated Treo platform.”
Bentley adds that BeFlared is the world’s first bridging stent specifically developed for FEVAR procedures. The company notes that the stent is crimped on a specially designed stepped balloon, which will reduce the number of steps that are needed for optimal deployment. Additionally, a third radiopaque marker aids in optimal positioning of the stents in the fenestration. BeFlared has received CE certification from TÜV Süd and the first-in-human procedure was performed by Stéphan Haulon (Université Paris-Saclay and Hôpital Marie Lannelongue, GHPSJ, Paris, France) in November 2024.
“By partnering with Terumo Aortic, we’re advancing BeFlared’s role as the go-to bridging stent for FEVAR. Already available in most key markets, its value is being demonstrated through strong outcomes led by KOLs [key opinion leaders]. This study will further solidify its impact in treating complex aortic aneurysms. Terumo Aortic’s fenestrated Treo platform is an excellent complement, and together, we are setting new standards in patient care,” said Sebastian Büchert, CEO of Bentley.
“The combination of fenestrated Treo and BeFlared is designed to set a new benchmark for FEVAR procedures by offering both ease of use and reduced complications for patients,” the press release reads. “Together, Terumo Aortic and Bentley are driving innovation in the field of aortic disease treatment.”
