InVera Medical, a Galway based medtech company, has received European regulatory approval for a new minimally invasive device designed to help physicians deliver treatment more effectively to diseased leg veins, including varicose veins.
The approval, known as a CE Mark, allows the company’s InVera Infusion Device to be marketed and used across the European Union.
Unlike many existing technologies that burn the vein, the InVera device uses a non-thermal approach. The procedure is carried out in a doctor’s office, requires only a single injection of local anaesthetic, and does not need specialised hospital equipment.
This represents a major step forward in expanding non-thermal options for physicians in the management of Chronic Venous Disease.
The device uses a thin catheter inserted into the vein under ultrasound guidance, a technique already familiar to many physicians, and is designed to enhance the infusion of physician-specified agents more effectively inside the vein.
Chronic Venous Disease affects around one in four adults and can progress from visible varicose veins to painful leg ulcers if left untreated.
Despite affecting an estimated 120 million people across Europe and the US, only around 1% of those living with venous disease currently receive interventional treatment each year, underlining a significant gap in care that InVera aims to address.
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.”
Founded in 2018, InVera Medical develops catheter-based technologies for vein disease. The company’s mission is driven by a patient-first, scientifically grounded approach to innovation of safe and effective medical devices.
The InVera Infusion device is CE Marked for use in the EU. It is not currently available in the US or any other international market.
