Endospan’s Nexus Aortic Arch Stent Graft System Evaluated at 1 Year in TRIOMPHE Pivotal Study 

February 3, 2026—Endospan, a privately held, Israel-based company focused on the endovascular repair of aortic arch disease, announced 1-year results of the TRIOMPHE investigational device exemption study of its Nexus aortic arch stent graft system. The findings were presented at STS 2026, the 62nd annual meeting of the Society of Thoracic Surgeons.

According to the company, TRIOMPHE is a prospective, multicenter, three-arm trial designed to assess the safety and effectiveness of the Nexus system in patients with aortic arch pathologies (ie, dissection, aneurysm, penetrating aortic ulcer/intramural hematoma).

Endospan stated that the 1-year results for the 94 high surgical risk patients in the three arms are promising for aortic arch treatment in Zone 0.

As outlined in the Endospan press release, the following data were shared at STS:

• Lesion-related mortality at 1 year (31-365 days) was 0.0%; at 30 days, it was 6.4% (n = 6).
• Overall disabling stroke rate for bypass plus Nexus was 1.1% (n = 1; 0 for post bypass and 1 for post Nexus) at 1 year; at 30 days, the rate was 7.4% (n = 7; 1 for post bypass and 6 for post Nexus).
• The rate of renal failure was 0.0% at 1 year, as well as at 30 days.

Further, core lab analysis of stent graft sealing showed no type III or IV endoleaks; three patients had a type Ia or Ib endoleak, suggesting good sealing through 12 months, noted Endospan.

In the United States, the Nexus system is pending premarket approval review by the FDA which includes a multistage, in-depth evaluation of the available safety and efficacy data. Outside of the United States, device availability is subject to local regulations and guidelines, advised Endospan.