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Войти в исследования Journal of vascular surgery. Venous and lymphatic disorders · 2026
A pilot study of the InVera Infusion Device: Twelve-month outcomes in the treatment of incompetent saphenous veins.
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Bihari Imre, Madden Stephen, Phelan Nigel, Kabnick Lowell S
Аннотация
OBJECTIVE: The InVera Infusion Device is a novel catheter designed for the delivery of sclerosant agents during non-thermal, non-tumescent (NTNT) ablation of incompetent superficial truncal veins of the lower extremity. This device pilot study aimed to evaluate the technical success, safety, and 12-month clinical outcome.
METHODS: A single-center, prospective pilot study enrolled 10 patients with primary symptomatic axial reflux who underwent chemical ablation procedures with sclerosant delivery using the InVera Infusion Device. Primary outcomes assessed were technical procedural success, adverse events, Revised Venous Clinical Severity Score (rVCSS), patient-reported outcomes (PROs) based on a HASTI (Heaviness, Achiness, Swelling, Throbbing, Itching) symptom questionnaire and anatomical success rates from duplex ultrasound examination at baseline, 1 week, 8 weeks, 3, 6, and 12 months post procedure. Baseline and 12 months post procedure were compared for both the rVCSS and the HASTI results using a paired t-test and a Wilcoxon signed-rank test respectively RESULTS: Technical procedural success was 100%. There were no device-related adverse events or serious adverse events including no deep vein thrombosis recorded throughout the follow-up period. Clinician assessed rVCSS and patient reported HASTI scores both showed statistically significant reductions from baseline to 12 months (adjusted p = 0.03 for both). Ultrasound-based anatomical assessment at 12 months demonstrated elimination of abnormal reflux and complete or partial occlusion in 90% of patients.
CONCLUSIONS: The InVera Infusion device provides a safe and effective technique for the delivery of sclerosant agents as part of the management of incompetent saphenous veins, demonstrating favorable 12-month anatomical, clinical and patient reported outcomes in this pilot cohort.
METHODS: A single-center, prospective pilot study enrolled 10 patients with primary symptomatic axial reflux who underwent chemical ablation procedures with sclerosant delivery using the InVera Infusion Device. Primary outcomes assessed were technical procedural success, adverse events, Revised Venous Clinical Severity Score (rVCSS), patient-reported outcomes (PROs) based on a HASTI (Heaviness, Achiness, Swelling, Throbbing, Itching) symptom questionnaire and anatomical success rates from duplex ultrasound examination at baseline, 1 week, 8 weeks, 3, 6, and 12 months post procedure. Baseline and 12 months post procedure were compared for both the rVCSS and the HASTI results using a paired t-test and a Wilcoxon signed-rank test respectively RESULTS: Technical procedural success was 100%. There were no device-related adverse events or serious adverse events including no deep vein thrombosis recorded throughout the follow-up period. Clinician assessed rVCSS and patient reported HASTI scores both showed statistically significant reductions from baseline to 12 months (adjusted p = 0.03 for both). Ultrasound-based anatomical assessment at 12 months demonstrated elimination of abnormal reflux and complete or partial occlusion in 90% of patients.
CONCLUSIONS: The InVera Infusion device provides a safe and effective technique for the delivery of sclerosant agents as part of the management of incompetent saphenous veins, demonstrating favorable 12-month anatomical, clinical and patient reported outcomes in this pilot cohort.