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InVera Infusion Device is indicated for the infusion of physician-specified agents, including sclerosant, into veins of the peripheral vasculature (e.g., superficial veins, saphenous veins).

The InVera Infusion Device is a minimally invasive, single-use, disposable catheter system designed for the controlled infusion of physician-specified agents into the superficial veins of the lower limb.

The InVera Infusion Device has been designed specifically for use in the peripheral vasculature, including the saphenous veins and related superficial veins of the lower limb, to ensure controlled navigation to the target site. It is typically introduced at the thigh, knee or ankle level via a 5Fr Introducer sheath. The reinforced catheter design delivers pushability supporting direct access, without the requirement for a guidewire. The echogenic distal catheter section is visualized by ultrasound during navigation to the target site.

The nitinol helical coil is deployed from its constrained position in the distal catheter by a pin-and-pull handle mechanism. The helical coil can be recaptured and repositioned under direct ultrasound visualization to ensure proper placement in the target vein. The radial outward force of the 6mm diameter coil and its micro-textured lumen engaging surface is intended to stimulate venospasm resulting in shrinkage of the target vein diameter., to cause dilution of the infused agent.

Prior to infusion of agents, the helical coil is withdrawn in the target vein by catheter shaft withdrawal by the user. This results in localized venospasm in the target infusion area and exposure of the subendothelial layer secondary to mechanical disruption by the lumen engaging surface of the helical coil.

Infusion is performed by attachment of a syringe to the 3-way tap connected by an extension tube to the catheter handle luer hub. The infused agent is delivered through the catheter for end-hole infusion to the target zone. Infusion is typically performed at intervals across the target zone depending on the clinical requirement. Following completion of infusion, the helical coil is recaptured, and the device is removed.

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