iHub client company InVera Medical Receives FDA Clearance for InVera Infusion Device – a Novel Non-Thermal Catheter for Enhanced Infusion of Sclerosant for Chronic Venous Disease

GALWAY, Ireland, April 7, 2026 /PRNewswire/ — InVera Medical, a medical device company focused on advancing minimally-invasive technologies for Chronic Venous Disease, has received FDA 510(k) clearance for the InVera Infusion Device, a new minimally invasive device designed to help physicians deliver treatment more effectively to diseased leg veins, including varicose veins.

Chronic Venous Disease (CVD) affects one in four adults and can progress from visible varicose veins to painful leg ulcers, if left untreated. Despite affecting over 120 million people across the US and Europe, only 1% of those living with venous disease currently receive treatment each year, underlining a significant gap in care that InVera aims to address.

The first device that mechanically prepares the vein wall to enhance sclerosant infusion to deeper layers, enabling a procedure that combines both safety and effectiveness for patients with CVD.

Existing thermal burning technologies require multiple painful injections to deliver tumescent anesthesia prior to treatment, while current non-thermal methods are limited by inferior efficacy that often necessitates repeat procedures or involve permanent glue implantation. In contrast, the InVera Infusion Device offers a more comfortable, effective, non-thermal and non-implant alternative for CVD patients.

The InVera Infusion Device features a 5Fr catheter with a novel helical coil to mechanically prepare the vein wall by disrupting the inner media layer for enhanced infusion of sclerotherapy agents. This minimally invasive procedure offers significant improvements in procedural efficiency for physicians, requiring only a single injection of local anesthetic, which supports faster patient recovery.

“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.

“FDA 510(k) clearance and CE Mark approval are major milestones for InVera Medical, enabling our limited market release in select US and European centers this year. With dual approvals and promising 12-month pilot data demonstrating strong safety and procedural outcomes, we are excited to offer CVD patients and physicians a less invasive and highly effective option. Our technology aims to expand the fastest growing non-thermal segment of the superficial venous reflux market which sees over 1 million annual procedures in the US alone.” said Stephen Cox, CEO and Co-Founder of InVera Medical.

InVera Medical, founded in 2018, creates catheter-based solutions for vein disease with a patient-focused and scientific approach to device innovation.

The InVera Infusion Device is approved for use in the US and EU within its indications.

This achievement also represents an important milestone for the ATU iHubs ecosystem, as InVera Medical becomes the second client company to receive FDA clearance, following Rockfield Medical Devices and its Mobility+™ enteral feeding system. It reflects the strength of the innovation environment across ATU’s centres, supporting companies from early-stage development through to global regulatory approval and market entry.

We congratulate the entire InVera Medical team on this outstanding achievement and look forward to supporting their continued growth as they bring this technology to patients and clinicians worldwide.