Galway, Ireland-based InVera designed its minimally invasive device to help physicians deliver treatment more effectively to diseased leg veins, including varicose veins. It aims to treat chronic venous disease (CVD), which currently faces a significant gap in care, the company says.
InVera says its device differs from existing technologies that burn the vein, using a non-thermal approach. The procedure takes place in a doctor’s office and requires just a single injection of local anesthetic. It does not require specialized hospital treatment. The device uses a thin, 5Fr catheter inserted into the vein under ultrasound guidance. It aims to enhance infusion for physician-specified agents more effectively inside the vein.
The infusion system’s catheter has a novel helical coil designed to mechanically prepare the vein wall. It disrupts the inner media layer for enhanced infusion of sclerotherapy agents. This can improve procedural efficiency for physicians, requiring just a single injection of local anesthetic and supporting faster recovery.
InVera says the approval marks a significant step forward in expanding non-thermal options for physicians managing CVD. FDA clearance comes on the heels of CE mark approval, which the company earned in February.
(Learn more about Ireland’s medtech ecosystem here and read an interview about the company’s growing medtech prospects with IDA Ireland here.)
Commentary from company officials
Nigel Phelan, chief medical officer and co-founder of InVera Medical, said:
“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.”
Stephen Cox, CEO and co-founder of InVera Medical, said:
“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 U.S. alone.”
