European CE Mark Approval Granted to InVera Medical’s New Vein Infusion Device

InVera Medical has received CE Mark approval for a new minimally invasive device designed to help physicians deliver treatment more effectively to diseased leg veins, including varicose veins.

Unlike many existing technologies that burn the vein, the InVera device uses a non-thermal approach. The procedure is conducted in a doctor’s office, requires only a single injection of local anesthetic, and does not need specialized hospital equipment. This represents a major step forward in expanding non-thermal options for physicians in the management of chronic venous disease, according to the company.

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 about one in four adults and can progress from visible varicose veins to painful leg ulcers if left untreated. While it is estimated to affect more than 120 million people across Europe and the United States, around 1% of those living with chronic venous disease currently receive interventional treatment annually, underlining a significant gap in care that InVera aims to address.

“Securing CE Mark is a major milestone for InVera Medical and a significant step towards making this technology available to patients across Europe,” InVera Medical Co-Founder/CEO Stephen Cox said. “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 Irish company’s mission is driven by a patient-first, scientifically grounded approach to the innovation of safe, effective medical devices. The InVera Infusion device is CE Marked for use in the EU but is not currently available in the United States or any other international market.