Endospan has reported promising 30-day results for its Nexus Aortic Arch Stent-Graft System from the TRIOMPHE clinical study, suggesting its potential as a viable alternative to open aortic arch surgery for high-risk patients.
These findings were presented at the American Association for Thoracic Surgery (AATS) Annual Meeting in Seattle.
Conducted across 30 centres in the US and one in New Zealand, the TRIOMPHE study is evaluating the safety and efficacy of the Nexus device in treating aortic dissection, aneurysm, and penetrating aortic ulcer (PAU)/intramural haematoma (IMH).
The core lab analysis reported no Type Ia, Type Ib, or Type III endoleaks, indicating effective sealing by the stent-graft after 30 days, especially significant for Zone 0 aortic arch treatment.
Among the 54 participants, no operative mortality was observed, while the 30-day mortality rate was 9.2% (n=5). Disabling strokes were reported at 5.6% (n=3), with 1.9% (n=1) post-bypass and 3.7% (n=2) post-Nexus procedure. The study noted no cases of renal failure or paraplegia.
Endospan CEO Kevin Mayberry said: “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.
“We look forward to continue our leadership in clinical development of Aortic Arch repair in the future.”
The Nexus system is currently available in Europe and remains intended for investigational use in the US.
As a bi-modular off-the-shelf device, it offers a minimally invasive option for patients who are unsuitable for traditional open-chest surgery methods.
Endospan specialises in endovascular repair for aortic arch diseases such as aneurysms and dissections.
The Nexus Aortic Arch Stent Graft System holds CE Mark approval for patients with dilative lesions in or near the aortic arch.
While minimally invasive endovascular repair is standard for Abdominal Aortic Aneurysm (AAA), options for those with aortic arch disease have been limited to more invasive open-chest surgery, which involves longer hospital stays and recovery times.
