The Galway, Ireland-based company designed its device to help deliver treatment more effectively to diseased leg veins, including varicose veins. CE mark approval enables the marketing of the InVera Infusion Device across the European Union.
According to a news release, the InVera device differs from existing technologies that burn the vein, using a non-thermal approach. The procedure takes place in a doctor’s office and requires just a single injection of local anesthetic. It does not require specialized hospital treatment.
The device uses a thin catheter inserted into the vein under ultrasound guidance. It aims to enhance infusion for physician-specified agents more effectively inside the vein.
InVera says the approval marks a significant step forward in expanding non-thermal options for physicians managing chronic venous disease (CVD).
“Securing CE Mark is a major milestone for InVera Medical and a significant step towards making this technology available to patients across Europe. Our focus has been on developing a less-invasive, effective non-thermal approach that fits easily into existing clinical practice while improving the treatment experience for both physicians and patients,” said Stephen Cox, CEO and co-founder of InVera Medical.
