Primary Endpoint Results Published From Pivotal Study of Terumo Aortic’s Treo EVAR Device

January 26, 2021—Terumo Aortic announced the publication of the primary endpoint results from the investigational device exemption (IDE) pivotal study of the company’s Treo abdominal aortic stent graft system for the endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms. Matthew J. Eagleton, MD, et al published the findings online ahead of print in the Journal of Vascular Surgery.

In May 2020, Terumo Aortic announced FDA approval of the Treo device. The company launched the device in the United States in September 2020. It has been available in Europe since 2015.

According to the company, the multicenter, nonrandomized, IDE, pivotal study assessed the safety and effectiveness of Treo over a 3-year period. Investigators enrolled 150 patients with infrarenal abdominal aortic or aortoiliac aneurysms who were treated at 29 centers across the United States.

The completed primary safety and effectiveness endpoint analysis demonstrated 100% technical success with a 0.7% incidence of major adverse events at 30 days and 93.1% successful aneurysm treatment at 1 year. Follow-up in the study continues.

A high percentage of patients had positive aortic remodeling, with 54.3% with had aneurysm sac shrinkage > 5 mm at 3 years. This is in line with previous studies such as the global RATIONALE registry, noted the company.

In Terumo Aortic’s press release, Dr. Eagleton, Principal Investigator of the study, stated, “Treo is a new-generation EVAR device designed to improve deployment and fixation and increase the potential to treat more complex aortas with a wider range of sizing options and a number of engineering features to ensure durability for better longer-term outcomes. Research continues with ongoing follow-up of the IDE cohort for a maximum of 10 years.”

Additionally, study investigator Michael C. Stoner, MD, addressed the consistently good sac regression observed with Treo, commenting, “Worldwide experience with this device along with publications from our groups have already suggested that Treo is linked to positive remodeling. Certainly, data to 3 years in the IDE study are in line with those earlier findings and, as we gain more experience with Treo, it will be beneficial to develop an even better understanding of the physiological factors contributing to sac regression.”