InVera Medical Receives FDA Clearance for InVera Infusion Device for Chronic Venous Disease
InVera Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its InVera Infusion Device, a novel non-thermal catheter designed to improve the delivery of sclerosant therapy in diseased leg veins, including varicose veins.
Chronic Venous Disease affects approximately one in four adults and can progress to severe complications such as leg ulcers if untreated.
Despite its prevalence, treatment rates remain low, with only a small proportion of patients receiving intervention annually, highlighting a significant unmet clinical need.
The InVera Infusion Device introduces a mechanical approach that prepares the vein wall to enhance penetration of sclerosant agents.
The system uses a 5Fr catheter with a helical coil designed to disrupt the inner vein layer, enabling more effective infusion of treatment while requiring only a single local anaesthetic injection.
The device aims to address limitations associated with thermal and existing non-thermal therapies, which may involve multiple injections, variable efficacy, or implant-based approaches.
It is designed to improve procedural efficiency, reduce patient discomfort, and support faster recovery in office-based settings.
According to InVera Medical leadership, FDA clearance and CE Mark approval support limited market introduction in select US and European centres, alongside continued clinical evaluation of safety and procedural outcomes.
