InVera Infusion Device

The InVera Infusion Device is a minimally invasive, single-use catheter system designed to deliver physician-specified agents, including sclerosants, into peripheral veins (superficial and saphenous veins). It features a nitinol helical coil with a micro-textured surface that is deployed and recaptured under ultrasound guidance to induce localized venospasm and expose the subendothelial layer, then withdrawn to allow infusion of therapeutic agents.

The InVera uses a mechanical 6 mm nitinol helical coil with micro-textured lumen-engaging surface and a manual pin-and-pull handle mechanism for deployment/recapture, whereas the predicate ClariVein IC uses a motorized rotating stainless-steel wire at 3500 RPM with an angulated ball-tip. The InVera is 5 Fr diameter and 100 cm length versus the predicate at 3 Fr and 45–85 cm. Both are end-hole infusion catheters for peripheral vasculature delivery, with no motorized components in the InVera design.

ISO 10555-1 (cardiovascular catheter specifications), ISO 10555-3 (testing), ISO 13485 (design controls and QMS), IEC 62366-1 (human factors/usability), AAMI TIR42 (particulate evaluation), FDA Guidance on Peripheral PTA and Specialty Catheters, FDA Guidance on Human Factors and Usability Engineering, and literature-based methods for simulated use, dimensional analysis, deployment/recapture, catheter bond strength, flexibility, and kink testing.

The InVera Infusion Device has the same intended use, overall design intent, principle of operation (end-hole infusion into peripheral vasculature), and design features as the predicate ClariVein IC. Although there are technological differences—mechanical coil versus motorized wire—both deliver physician-specified agents for peripheral infusion via minimally invasive catheters. Performance testing including simulated use, dimensional analysis, deployment/recapture studies, and a comparative GLP animal study with clinical data demonstrate that the technological differences do not raise new questions regarding safety or efficacy, supporting substantial equivalence.