Endospan has announced positive one-year results from the TRIOMPHE study evaluating its NEXUS aortic arch stent-graft system.
The multi-centre, three-arm, prospective trial assessed the effectiveness and safety of the system in patients with aneurysm, dissection, and penetrating aortic ulcer (PAU) / intramural haematoma (IMH).
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The one-year data covers 94 high surgical risk patients across all arms, focusing on treatment in Zone 0 of the aorta, a complex segment with associated risks such as mortality and stroke.
Core laboratory analysis indicated no Type III or IV endoleaks, with only three patients experiencing an Ia or Ib endoleak, suggesting good sealing over 12 months.
These outcomes are significant given the challenges in treating thoracic aortic arch disease, which affects more than 120,000 patients annually in Europe and the US. Only 25% of these patients are diagnosed or treated.
Open surgical repair of the aortic arch continues to carry high mortality and morbidity rates. Many patients are unsuitable for surgery due to perioperative risk or anatomical considerations. The lack of approved endovascular devices for the arch has limited minimally invasive options, making treatment selection difficult for some individuals.
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By GlobalDataIn the US, the NEXUS system is pending premarket approval (PMA) review by the Food and Drug Administration (FDA). Availability outside the US depends on local regulations and guidelines.
Endospan CEO Kevin Mayberry said: “NEXUS was designed specifically for the total aortic arch. We are pleased to see that the one-year data for the TRIOMPHE study aligns with the pre-and-post commercialisation data that has been published in Europe.
“The TRIOMPHE data continues to support NEXUS as a straightforward, minimally invasive solution for aortic arch repair that allows for procedural consistency with reliable patient outcomes.”
In October 2024, Endospan completed enrolment in the primary arm of a clinical trial that evaluated its stent graft for the treatment of aortic arch disease.
