InVera Medical Wins FDA Clearance for Non-Thermal Vein Infusion Device

The FDA has granted 510(k) clearance to InVera Infusion Device, a minimally invasive, non-thermal catheter designed to improve treatment of chronic venous disease (CVD), including varicose veins.

The clearance marks a key milestone for the Galway, Ireland-based medtech company, enabling commercialization of the device in the US following earlier European CE mark approval.

Chronic venous disease affects roughly one in four adults and can progress from visible varicose veins to debilitating complications such as leg ulcers if left untreated. Despite impacting more than 120 million people across the US and Europe, only about 1% of patients receive interventional treatment annually, highlighting a significant unmet need.

Current thermal ablation methods typically require multiple injections of tumescent anesthesia and carry risks such as nerve injury, bruising and prolonged recovery.

In contrast, InVera’s new device is a non-thermal, non-implant alternative to conventional vein treatments that only requires a single injection of local anesthetic, supporting faster patient recovery.

The InVera infusion device uses a 5Fr catheter equipped with a helical coil to mechanically prepare the vein wall, enhancing delivery of sclerosant agents into deeper tissue layers. A sclerosant is a chemical compound injected into a vein to irritate and damage its inner lining, causing the vessel to collapse and eventually be absorbed by the body.

Unlike heat-based technologies, the device works by disrupting the inner vein wall to optimize drug uptake, creating a more favorable environment for sclerosant therapy. This mechanical approach may reduce the need for repeat procedures often associated with existing non-thermal options.

The device is designed for use in outpatient settings and integrates into existing ultrasound-guided workflows, potentially expanding access to treatment.

“There is a clear clinical need for a non-thermal procedure that is both less invasive and highly effective for CVD. Existing thermal options involve many painful injections, risk skin and nerve injury and often lead to significant bruising, swelling and prolonged recovery periods for patients making them poorly suited to the Office Based Lab (OBL) setting. Current non-thermal methods can be ineffective, painful or burdened by the risk of permanent glue implantation. The InVera Infusion Device provides a safer, less invasive and effective alternative that can benefit millions of patients,” said Nigel Phelan, Chief Medical Officer and Co-Founder of InVera Medical, in a press release announcing the clearance.

InVera says early clinical data are promising, with 12-month pilot study results expected to be presented at the 2026 Charing Cross Vascular Symposium on April 21.

With both FDA clearance and CE mark approval secured, InVera is positioned to enter the growing non-thermal venous treatment market, which includes over 1 million procedures annually in the US alone.

As the field shifts toward less invasive, patient-friendly approaches, the InVera Infusion Device could represent a meaningful step forward in closing the treatment gap for chronic venous disease.