Terumo Aortic and Bentley Collaborate on FEVAR Clinical Study 

October 1, 2025—Terumo Aortic and Bentley announced their partnership in a clinical study in the United States to obtain 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, the companies advised.

According to Terumo Aortic and Bentley, the collaboration aims to introduce their FEVAR solutions to the United States, targeting the treatment of patients with complex abdominal aortic aneurysms, specifically juxtarenal and suprarenal aneurysms. After completion of the joint clinical study and FDA approval, the companies plan to independently market their products in the United States.

The press release stated that Terumo Aortic’s fenestrated Treo device is a patient-specific solution tailored to the anatomic conditions and clinical needs for treating aortic aneurysms. To ensure perfusion of vital organs, the fenestrated Treo device can be designed to include up to five fenestrations, requiring reliable bridging stents to maintain perfusion to the target vessels.

Bentley’s BeFlared is a bridging stent specifically developed for FEVAR procedures. The stent is crimped on a stepped balloon to reduce the number of steps needed for optimal deployment. Additionally, a third radiopaque marker aids in the optimal positioning of the stents in the fenestration.

On September 24, 2025, Bentley announced that the FDA granted Breakthrough Device designation for the BeFlared.

In November 2024, Bentley announced TÜV Süd certificate for BeFlared in complex aortic interventions in all countries that recognize CE Mark approval; the company also announced the first-in-human procedure was performed by Professor Stéphan Haulon, MD, in Paris, France.