Terumo Aortic’s Fenestrated TREO Earns FDA Breakthrough Device Designation
Published: 30 Mar 2026
Author: Precedence Research
Terumo Aortic’s fenestrated TREO abdominal stent-graft system has been designated a Breakthrough Device by the U.S Food and Drug Administration(FDA). The FDA Breakthrough Device designation is a program established by the FDA to speed up regulatory review and facilitate prompt patient access to new medical innovations for life-threatening conditions with unmet medical need. The Fenestrated TREO system is a custom-made endovascular stent graft system for repairing complex abdominal aortic aneurysm anatomy. This system is specifically designed for juxtarenal and suprarenal aneurysm repairs where current AAA repair medical devices fall short. This device facilitates the customization of the stent graft with precise fenestrations to accommodate individual patient anatomy.
What does the Breakthrough Designation Mean?
The FDA’s Breakthrough Device program allows the development, evaluation and review of medical devices that may be able to bring more effective treatments to patients with serious and life-threatening conditions. By obtaining the breakthrough status, Terumo Aortic is able to work more closely with the FDA throughout the entire process, which may bring the device to the U.S market sooner. According to the company’s leadership, the technology behind the fenestrated TREO platform has the potential to give physicians and their patients a customized, minimally invasive treatment option for those with complex anatomy. This technology has the potential to provide minimally invasive treatments for aneurysms that involve critical branch arteries near the kidneys and visceral vessels.
The abdominal aortic aneurysm repair market size was calculated at USD 5.23 billion in 2025 and is predicted to increase from USD 5.50 billion in 2026 to approximately USD 8.60 billion by 2035, expanding at a CAGR of 6.10% from 2026 to 2035 as the demand grows for minimally invasive procedures, better stent grafts, faster patient recovery, and improved treatment outcomes.
Strategic Fit in the Abdominal Aortic Aneurysm Market
This milestone in the regulatory process occurs in the context of activity in the abdominal aortic aneurysm repair segment, where companies are increasingly focusing on innovating in fenestrated and low-profile stent grafts that treat complex disease states. The TREO system’s Breakthrough designation puts it in the same class with other advanced fenestrated products in development and further emphasizes the pace of innovation in endovascular solutions for the market.
A recent report by Precedence Research highlights that the abdominal aortic aneurysm repair market is benefiting from improvements in endovascular apparatus, imaging techniques, surgeon training, and patient monitoring.