Terumo Aortic’s Fenestrated Treo Abdominal Stent Graft System Granted FDA Breakthrough Device Designation

March 16, 2026—Terumo Aortic announced that the FDA has granted Breakthrough Device designation for the company’s fenestrated Treo abdominal stent graft system.

According to the company, the fenestrated Treo is a custom-made endovascular stent graft system developed to treat complex abdominal aortic aneurysms. The device is intended for the endovascular repair of juxtarenal and suprarenal (pararenal/paravisceral) abdominal aortic and aorto-iliac aneurysms, supporting treatment in cases where standard off-the-shelf devices may not provide an adequate anatomic fit.

Jim Rushworth, President of Terumo Aortic, and Jeffrey Mifek, Global Vice President of Clinical & Medical Affairs of Terumo Aortic, commented on the milestone in the company’s press release.

“The FDA’s Breakthrough Device designation for fenestrated Treo is very encouraging, and we look forward to close collaboration with the FDA as we work to advance treatment options for patients with complex abdominal aortic aneurysms,” stated Rushworth.

Mifek added, “This designation supports the potential for United States physicians to treat patients whose complex anatomy or clinical conditions makes traditional endovascular devices or open surgery unsuitable—addressing a significant unmet need. Fenestrated Treo offers a tailored, minimally invasive solution designed for challenging anatomies, including the ability to incorporate multiple fenestrations precisely aligned to a patient’s unique arterial branching pattern. This level of customization helps address the needs of patients with complex vessel configurations that off-the shelf devices can’t accommodate.”