Irish medical technology company InVera Medical has secured European regulatory approval for its innovative minimally invasive device designed to improve treatment of diseased leg veins, including varicose veins.

 

The CE Mark clears the way for the InVera Infusion Device to be marketed and used across the European Union, offering physicians a new non-thermal alternative to traditional vein therapies. Unlike many existing technologies that burn the vein, the device works through a single injection of local anaesthetic in a doctor’s office—without requiring specialised hospital equipment.

 

“This represents a major step forward in expanding non-thermal options for physicians in the management of Chronic Venous Disease,” the company said. The device uses a thin catheter guided by ultrasound—a technique familiar to many clinicians—to deliver physician-specified agents more effectively inside the vein.

 

Chronic Venous Disease affects roughly one in four adults and can escalate from visible varicose veins to painful leg ulcers if untreated. Despite impacting over 120 million people in Europe and the US, only around 1% currently receive interventional treatment annually, highlighting a significant care gap InVera aims to fill.

 

Stephen Cox, CEO and Co-Founder of InVera Medical, said: "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."