Endospan’s Nexus Aortic Arch Stent Graft System Evaluated in 30-Day TRIOMPHE Data

May 5, 2025—Endospan announced 30-day results of the statistical Dissection primary arm from the TRIOMPHE investigational device exemption (IDE) clinical study, which is evaluating the company’s Nexus aortic arch stent graft system.

The company stated that TRIOMPHE is a prospective, multicenter, three-arm trial designed to assess the safety and effectiveness of the Nexus device in patients with aortic arch pathologies. The three study arms are: Dissection, Aneurysm, and Penetrating Aortic Ulcer/Intramural Hematoma.

The data were presented during the late-breaking trial session at the American Association for Thoracic Surgery’s 105th annual meeting held May 2-5 in Seattle, Washington.

According to the Israel-based company, the 30-day results are promising for aortic arch treatment in Zone 0 with Nexus and suggest that the device may be an acceptable alternative to open aortic arch replacement in select patients at high risk for open surgery. Further, core lab analysis of stent graft sealing showed no type Ia, no type Ib, and no type III endoleaks, suggesting good sealing at 30 days, stated Endospan.

Specific findings for the TRIOMPHE study (N = 54), which were outlined in the company’s press release, included 0% operative mortality and 9.2% 30-day mortality (n = 5). The rate of overall disabling stroke was 5.6% (n = 3)—1.9% post bypass (n = 1) and 3.7% post Nexus (n = 2). There was no incidence of renal failure nor paraplegia.

Brad Leshnower, MD, is the TRIOMPHE study’s National Cardiac Principal Investigator and Ross Milner, MD, is its National Vascular Principal Investigator.

“The 30-day data from the TRIOMPHE study are highly encouraging for the treatment of aortic arch disease,” commented Dr. Leshnower in Endospan’s press release. “The low stroke rate, in particular, is a significant achievement. This data is very promising while we await 1-year follow up of the study patients.”

Dr. Milner added, “As a vascular surgeon, I am excited about the potential of the Nexus aortic arch stent graft to provide a less-invasive treatment option for patients with complex aortic arch pathologies.”

Endospan’s endovascular, off-the-shelf Nexus aortic arch stent graft system has received CE Mark approval and is currently available for sale in Europe. In the United States, it is intended for investigational use only, advised the company.