Terumo Aortic’s Fenestrated TREO Pivotal IDE Study Begins in the United States

November 19, 2025—Terumo Aortic announced enrollment of the first patient in the fenestrated TREO pivotal trial in the United States.

According to the company, the investigational device exemption (IDE) study is designed to evaluate the endovascular repair of juxtarenal and suprarenal aortic aneurysms using the company’s fenestrated Treo abdominal stent graft system. The clinical study will use the iCast covered stent system (Getinge) as a bridging stent, noted the press release.

Terumo Aortic advised that the study will be conducted at up to 45 health care institutions in the United States. Approximately 210 patients will be enrolled across three study arms: patients with juxtarenal aneurysms, those with suprarenal aneurysms, and those with chronic kidney disease. Patients will be followed for 5 years postprocedure.

The National Principal Investigator of the trial is Benjamin Starnes, MD, with the University of Washington in Seattle, Washington. The first patient was enrolled by J. Westley Ohman, MD, with the Washington University School of Medicine in St. Louis, Missouri.

“The fenestrated Treo stent graft system provides a revolutionary technology that is not available with any other endovascular graft in the United States today,” commented Dr. Starnes in Terumo Aortic’s press release. “I believe this product will become the gold standard for treating juxtarenal and suprarenal aneurysms.”