InVera Medical, a medical technology company based in Ireland, has received CE Mark approval for its InVera Infusion Device. This regulatory clearance enables the device to be marketed and used throughout the European Union.
The InVera Infusion Device offers a minimally invasive method for treating diseased leg veins, including varicose veins. Unlike many current treatments that use heat to close off veins, this device employs a non-thermal technique. The procedure is performed in a doctor's office, requires only one injection of local anaesthetic, and does not need specialized hospital equipment.
The system works by inserting a thin catheter into the vein using ultrasound guidance, a process familiar to many physicians. It is designed to deliver physician-specified agents more effectively inside the vein.
Chronic Venous Disease impacts about one in four adults and can worsen from visible varicose veins to painful ulcers if untreated. Although over 120 million people in Europe and the United States are affected by venous disease each year, only about 1% receive interventional treatment annually. This highlights an unmet need that InVera Medical 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.”
