Key result
Implantation of the VenoValve in patients with severe chronic venous insufficiency resulted in no late device-related adverse events and reduced mean reflux time by 61% at 2 years.
Why the study?
Chronic venous insufficiency involves improper functioning of lower limb vein valves with limited treatment options and no cure, warranting long-term clinical safety and performance evaluation of the bioprosthetic VenoValve.
Does the VenoValve improve clinical outcomes and reduce reflux in patients with severe chronic venous insufficiency?
Population
11 patients with C5 and C6 CVI and deep venous reflux
Comparison
Surgical implantation of bioprosthetic VenoValve into the midthigh femoral vein
Design
First-in-human study
Follow-up
2 years
Authors
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Supports VenoValve feasibility in CVI; leaves open efficacy confirmation in randomized trials.
Does the VenoValve improve clinical outcomes and reduce reflux in patients with severe chronic venous insufficiency?
The VenoValve demonstrated long-term safety and significant improvements in venous reflux, disease severity, and pain at 2 years in a small first-in-human cohort with severe chronic venous insufficiency.
Ulloa et al. (2023) studied Severe Chronic Venous Insufficiency (CVI) (n=11). VenoValve was evaluated on Device-related adverse events, reflux time, disease severity, and pain scores. Implantation of the VenoValve in patients with severe chronic venous insufficiency resulted in no late device-related adverse events and reduced mean reflux time by 61% at 2 years.
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