FDA Breakthrough Device Designation Granted for Terumo Aortic’s Fenestrated TREO System

Terumo Aortic has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for the Fenestrated TREO Abdominal Stent-Graft system.

“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,” Terumo Aortic President Jim Rushworth stated.

The company developed the custom-made endovascular stent-graft system to treat complex abdominal aortic aneurysms (AAA).  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 anatomical fit, Terumo Aortic bigwigs said.

The FDA’s Breakthrough Device Designation program is intended to fast-track the regulatory review process for certain medical technologies and device-led combination products that satisfy certain criteria; specifically, these include providing a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program aims to provide patients and healthcare professionals with timely access to important breakthrough medical devices by accelerating their development, assessment, and review.

“This designation supports the potential for U.S. physicians to treat patients whose complex anatomy or clinical conditions make traditional endovascular devices or open surgery unsuitable, addressing a significant unmet need,” stated Jeffrey Mifek, global vice president of Clinical & Medical Affairs. “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 an off-the-shelf device can’t accommodate.”

Terumo Aortic partners with customers to improve aortic care. The company develops a broad range of solutions that can be personalized for every patient, and is complementing its implantable device portfolio through digital technologies.

Terumo is a global medical innovation company founded in Tokyo in 1921. The firm provides a range of solutions for therapeutic procedures, hospital operations, and in life sciences in more than 160 countries and regions.