TRIOMPHE IDE Study of Endospan’s Nexus System Begins Enrollment

January 12, 2021—Endospan announced the first implant of the Nexus aortic arch stent graft system in the TRIOMPHE study, which is being conducted under an FDA investigational device exemption.

According to Endospan, TRIOMPHE is a multi-arm, multicenter, nonrandomized, prospective, clinical study to evaluate the safety and effectiveness of Nexus aortic arch stent graft system in treating thoracic aortic lesions involving the aortic arch. The study will enroll 100 patients at up to 30 sites.

The Nexus device is intended for investigational use only in the United States. It has received CE Mark approval and is available for sale in Europe, advised Endospan.

“Aortic arch repair has traditionally been one of the most technically challenging areas to repair,” commented Jean M. Panneton, MD, in the company’s announcement.

Christopher J. Barreiro, MD, added, “Some of these patients currently don’t have many options that don’t come with a high degree of risk. The TRIOMPHE study investigates if Nexus can safely extend minimally invasive, durable interventions to my patients while mitigating the risks of stroke, endoleaks, and migration."

Dr. Panneton is Vascular Surgery Chief and Program Director, Eastern Virginia Medical School in Norfolk, Virginia. Dr. Barreiro is a cardiothoracic surgeon at Sentara Mid-Atlantic Cardiothoracic Surgeons in Norfolk.