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Three-year data add to growing body of clinical evidence in support of VICI Venous Stent System
“improved immediately after baseline and stayed very stable through the whole follow-up period,” he informed LINC viewers. CEAP analysis showed that patients improved from baseline to 36 months—a “highly significant” result. In addition, Lichtenberg communicated that there were very few adverse events. “We had one access-site complication, one haematoma, and five stent reocclusions,” he detailed. Significantly, the investigators did not see any stent migration, venous rupture, infection, or pulmonary embolism during or after the intervention. The VICI Venous Stent System (Boston Scientific) is associated with These latest long-term data add to a excellent primary patency rates, with concomitant symptomatic growing body of evidence on the long-term improvement in Clinical-Etiological-Anatomical-Pathophysiological efficacy and safety of the VICI Venous Stent (CEAP) classification, directly after stenting and in long-term followSystem. up out to 36 months. In 2018, 12-month outcome data for 75 patients from this registry was published.1 THIS IS THE HEADLINE FINDING OF A The VICI Venous Stent System, In this study, the VICI Venous Stent System Michael subgroup analysis from the Arnsberg Venous Lichtenberg informed the audience, is a placed in the iliofemoral vein segment Lichtenberg registry, recently presented by one of the principal self-expanding laser-cut nickel-titanium in patients with symptomatic venous investigators, Michael Lichtenberg (Karolinen (nitinol) stent with a closed-cell design that outflow obstruction revealed no safety issues, had Hospital, Arnsberg, Germany) at LINC 2021 is available in diameters of 12, 14, and 16mm, and excellent primary patency, and substantial symptom (Leipzig Interventional Course; 25–29 January, in lengths of 60, 90, and 120mm. improvement. virtual). These long-term data add to a growing In terms of the patients included in the registry, Furthermore, Lichtenberg compared the present body of clinical evidence in support of the VICI Lichtenberg detailed that they had “clinically results to those of the already-published VIRTUS Venous Stent System, and make it the only significant chronic non-malignant obstruction of IDE trial, which showed similar results.2 In this dedicated venous stent with data out to three the iliofemoral venous segment”. Ninety such IDE trial, 12-month primary patency was 84%; after years—a crucial edge in a growing field. patients were involved, comprising 49 patients with 24 months, this was 79.4%. Patients also improved The European market for dedicated venous stents post-thrombotic syndrome and 41 patients with significantly during follow-up in the VIRTUS trial. is expanding, which has seen a parallel increase in compression syndromes such as May-Thurner. In a growing market with an expanding pool of available data. However, Lichtenberg stressed the Lichtenberg revealed a “very important” 96% data, the focus is now on longer follow-up, and importance of long-term results. “We are treating rate of primary patency after 36 months. He also this is where the VICI Venous Stent has an edge. very young patients with acute and chronic outflow announced positive clinical outcomes, first in terms The Arnsberg Venous registry subgroup analysis obstruction, and therefore I think there is a clear of the Venous Clinical Severity Score (VCSS) revealed excellent efficacy and safety out to 36 need to have long-term data available for this analysis. The patients included in the registry months, adding vital long-term data to an already treatment,” he said. established efficacy and safety profile. Concluding, In this context, Lichtenberg focused on the Lichtenberg informed LINC viewers that this stent Arnsberg Venous registry, which now has data is “a very good option for the treatment of acute and out to three years. He detailed that this was set up chronic outflow obstruction”. alongside the investigational device exemption (IDE) trial for the VICI Venous Stent System. “The References 1. Lichtenberg M, Breuckmann F, Stahlhoff WFhlhoff WF, et al. objective of the ongoing, prospective, single-arm, Placement of closed-cell designed venous stents in a mixed single-centre, non-randomised Arnsberg registry cohort of patients with chronic venous outflow obstructions subgroup analysis was to assess the safety and – short-term safety, patency, and clinical outcomes. Vasa 2018;47(6):1–7. effectiveness in achieving patency of target venous 2. Razavi MK, Black S, Gagne P, et al. Pivotal study of lesion through 36 months post stent placement with endovenous stent placement for symptomatic iliofemoral venous obstruction. Circ Cardiovasc Interv 2019;12:e008268. the VICI Venous Stent System,” he specified.
The VICI Venous Stent System is the only dedicated venous stent with data out to three years.”
Kaplan-Meier analysis of overall primary patency
VICI Venous Stent System
PI-968301-AA
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