Artivion has debuted long-term clinical data on two of its cardiac stent products, revealing each’s solution’s potential to offer extended benefits to patients.
This includes one-year data from the TRIOMPHE study (NCT04471909), which evaluated the clinical benefit of Artivion and Endospan’s NEXUS Aortic Arch System. After one year, 94% of the 94 high-risk patients enrolled onto this study avoided experiencing a lesion-related death.
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Meanwhile, 97% of patients remained free from endoleak-related reintervention following surgical fitting, with no observed formulation of clots in the branch of the aortic arch – while 91% remained free of disabling stroke.
This effect was seen in patients characterised as ASA risk class III and IV – meaning all the patients enrolled in the TRIOMPHE trial have severe systemic disease that either causes functional limitations or a consistent threat to life.
The Nexus Aortic Arch System is an off-the-shelf, two-stent, single-branch device that is fitted directly into the aortic arch. According to Artivion and Endospan, this stent allows surgeons to repair the aorta without the need for open heart surgery – improving outcomes for patients at high risk of adverse surgical outcomes.
Artivion first presented the results from the NEXUS TRIOMPHE IDE trial at the 62nd Society of Thoracic Surgery (STS) Annual Meeting held in New Orleans, from 29 January to 1 February 2026.
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By GlobalDataPERSEVERE trial reports positive two-year data
Alongside the success of its aortic stent, Artivion also posted positive results from the two-year follow-up on the PERSEVERE study (NCT05174767) at the 2026 STS Annual Meeting.
In this trial, Artivion tracked the clinical and radiographic outcomes in 93 patients who underwent open repair of an acute DeBakey type I aortic dissection with its Ascyrus medical dissection stent (AMDS), which is designed to stabilise the aorta and reduce the risk of further tearing.
Two years after the procedure, minimal additional mortality was recorded, with four patient deaths attributed to unrelated causes. At this timepoint, there was also a low rate of aortic reoperation, with 4.3% of patients requiring another procedure. Of those who did need another operation, Artivion noted that none were considered “unanticipated”.
Patients fitted with AMDS also experienced no new aortic tears, which can often occur within the inner layer of the artery after surgical repair of a type I aortic dissection. After two years, the diameter of the aorta also remained consistent, with an average 1.7mm diameter expansion of the artery’s lumen.
Aortic aneurysms remain strong area of growth
While several devices have now gained approval for use in patients with aortic aneurysms, a 2024 paper published in the Journal of Vascular Surgery notes that the number of deaths related to this cardiovascular event have seen an 81.6% increase between 1990 and 2019.
Though the paper notes that this observed increase was primarily driven by a rise in average age amongst the global population, the rise in deaths highlights the need for effective device strategies that can mitigate this impact.
Many companies within the medtech space have achieved this through the commercialisation of their aortic stent graft products, with Medtronic, Becton Dickinson (BD) and GE HealthCare Technologies being the top three companies, as highlighted by GlobalData.
GlobalData, parent company of Clinical Trials Arena, forecasts that the value of the aortic stent graft market will rise from $3.2bn in 2024 to $5bn in 2034 – expanding at a compound annual growth rate (CAGR) of 4.5%. Meanwhile, the wider cardiovascular devices market is set grow at a CAGR of 6.4% – reaching a value of $134.7bn in 2034.
