Endospan’s Nexus TRIOMPHE IDE Study Completes Enrollment of Primary Arm

October 21, 2024—Endospan announced the completion of enrollment for the primary arm of its TRIOMPHE investigational device exemption (IDE) clinical study for the company’s bimodular Nexus aortic arch stent graft. The commencement of enrollment was announced in January 2021.

The study is evaluating the safety and efficacy of the device for the endovascular treatment of aortic arch disease. The company plans to monitor the safety and efficacy for 1 year before submitting for FDA approval.

According to the company, the three-arm, nonrandomized TRIOMPHE IDE study is composed of patients with a variety of aortic arch pathologies enrolled at 30 aortic centers across the United States and one center in New Zealand.

In January 2024, Endospan announced the presentation of 30-day results of the first 22 patients enrolled in the TRIOMPHE IDE study were presented at STS 2024, the 60th annual meeting of the Society of Thoracic Surgeons held in San Antonio, Texas.

Ross Milner, MD, and Brad Leshnower, MD, are, respectively, the Vascular and Cardiac National Coprincipal Investigators for TRIOMPHE study.

Dr. Milner is Chief and Professor of Surgery, Section of Vascular and Endovascular Therapy; Vice-Chair, Clinical Affairs and Perioperative Services; and Codirector, Center for Aortic Diseases, at The University of Chicago Medicine in Chicago, Illinois.

Dr. Leshnower is Professor of Surgery, Division of Cardiothoracic Surgery, Department of Surgery, and Director of Thoracic Aortic Surgery at Emory University School of Medicine in Atlanta, Georgia.

“The Nexus device has the potential to revolutionize the treatment of aortic arch disease by offering a less-invasive alternative to open surgery,” commented Dr. Milner in Endospan’s press release. “We are eager to see the results of this study regarding midterm durability and patient outcomes.”

Dr. Leshnower added, “We are excited to be part of this groundbreaking study. While the early results from the TRIOMPHE study presented at STS this year suggest that the Nexus system can be used safely to treat aortic arch disease in a high-risk surgical cohort with a low rate of stroke, we anxiously await the results from the full cohort.”

In March 2019, Endospan announced European CE Mark approval for the Nexus stent graft system for the endovascular repair of aortic arch disease comprising both aneurysms and dissections.