Positive Study Results Linked to Endospan’s NEXUS Aortic Stent-Graft

Endospan is touting 30-day study results suggesting its NEXUS Aortic Arch Stent-Graft System might be an acceptable alternative to open aortic arch replacement for certain patients.

The company shared results from the statistical Dissection Primary Arm within the TRIOMPHE Investigational Device Exemption (IDE) clinical study, which evaluated the NEXUS Aortic Arch Stent-Graft, the first and only CE‑mark approved off‑the‑shelf endovascular aortic arch branch system.

“We are very encouraged by the results of the first ever presented data of Endovascular Aortic Arch Repair in Zone 0 in a Pivotal IDE Study,” Endospan CEO Kevin Mayberry said. “We look forward to continue our leadership in clinical development of Aortic Arch repair in the future.”

The TRIOMPHE study is a prospective, multicenter, three-arm trial designed to NEXUS Aortic Arch Stent Graft’s safety and effectiveness in patients with aortic arch pathologies (dissection, aneurysm, PAU/IMH).

The TRIOMPHE study’s 30-day results are promising for aortic arch treatment in Zone 0 with the NEXUS Aortic Arch Stent-Graft System. The data results suggest the NEXUS device may be a favorable alternative to open aortic arch replacement in select patients at high risk for open surgery.

Study results indicate no operative mortality, and a 9.2% 30-day mortality (five of 54 patients). Overall disabling stroke (bypass plus NEXUS) was 5.6% (three patients), post bypass mortality was 1.9% (one patient) and post-NEXUS mortality was 3.7% (two patients). No patients suffered renal failure or paraplegia.

“The 30-day data from the TRIOMPHE study are highly encouraging for the treatment of aortic arch disease,” said Dr. Brad Leshnower, national cardiac principal investigator. “The low stroke rate, in particular, is a significant achievement. This data is very promising while we await one-year follow up of the study patients.”

Further, core lab analysis of stent-graft sealing shows no Type Ia, no Type Ib and no Type III endoleaks, suggesting good sealing at 30-day. The TRIOMPHE study is ongoing, and longer-term follow-up will provide further insights into the safety and effectiveness of the NEXUS Aortic Arch Stent-Graft System.

“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,” said Dr. Ross Milner, national vascular principal investigator.

Privately held Endospan, headquartered in Herzlia (Tel Aviv), Israel, is a pioneer in the endovascular repair of aortic arch disease including aneurysms and dissections. Endospan’s NEXUS Aortic Arch Stent Graft System is the first endovascular off-the-shelf system with CE Mark to treat a greatly underserved group of patients diagnosed with a dilative lesion in, or near the aortic arch. While minimally invasive endovascular repair has been the standard of care for abdominal aortic aneurysm (AAA), aortic arch disease patients with aneurysms or dissections have had little choice but to undergo open-chest surgery with its invasiveness and risks, lengthy hospitalization periods, and prolonged recuperation.

NEXUS Aortic Arch Stent Graft System is currently available for sale in Europe and is intended for investigational use only in the United States.