InVera Medical Receives FDA Clearance for Novel Non-Thermal Catheter Device for Chronic Venous Disease Treatment
核心洞察
InVera Medical (搜索) has received FDA 510(k) clearance for its InVera Infusion Device, a novel non-thermal catheter designed to enhance sclerosant delivery for chronic venous disease treatment.
The device features a 5Fr catheter with a helical coil that mechanically prepares vein walls by disrupting the inner media layer, requiring only a single local anesthetic injection.
Chronic venous disease affects one in four adults and over 120 million people across the US and Europe, yet only 1% currently receive treatment annually.
InVera Medical (搜索) has achieved a significant regulatory milestone with FDA 510(k) clearance for its InVera Infusion Device, marking the introduction of the first device that mechanically prepares vein walls to enhance sclerosant infusion for chronic venous disease (CVD) treatment. The Ireland-based medical device company also secured CE Mark approval, enabling market entry in both the United States and Europe.
Addressing a Significant Treatment Gap
Chronic venous disease 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, highlighting a substantial gap in care that InVera aims to address.
The superficial venous reflux market sees over 1 million annual procedures in the US alone, with the non-thermal segment representing the fastest growing category. Current treatment options present significant limitations that have hindered broader adoption and patient satisfaction.
Technical Innovation and Clinical Advantages
The InVera Infusion Device features a 5Fr catheter equipped with a novel helical coil designed to mechanically prepare the vein wall by disrupting the inner media layer. This mechanism enables enhanced infusion of sclerotherapy agents to deeper layers, combining both safety and effectiveness for CVD patients.
The device addresses key limitations of existing technologies. Current thermal burning technologies require multiple painful injections to deliver tumescent anesthesia prior to treatment, while non-thermal methods are often limited by inferior efficacy that necessitates repeat procedures or involves permanent glue implantation.
"There is a clear clinical need for a non-thermal procedure that is both less invasive and highly effective for CVD," said Nigel Phelan, Chief Medical Officer and Co-Founder of InVera Medical (搜索). "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."
Procedural Efficiency and Patient Benefits
The minimally invasive procedure offers significant improvements in procedural efficiency for physicians, requiring only a single injection of local anesthetic, which supports faster patient recovery. This represents a substantial improvement over thermal alternatives that require multiple painful injections and often result in prolonged recovery periods.
"Current non-thermal methods can be ineffective, painful, or burdened by the risk of permanent glue implantation," Phelan noted. "The InVera Infusion Device provides a safer, less invasive and effective alternative that can benefit millions of patients."
Clinical Data and Market Launch
Encouraging 12-month pilot clinical study results demonstrating strong safety and procedural outcomes will be presented by Key Opinion Leader Dr. Lowell Kabnick at the Charing Cross Vascular Symposium in London on April 21st, 2026.
"FDA 510(k) clearance and CE Mark approval are major milestones for InVera Medical (搜索), enabling our limited market release in select US and European centers this year," said Stephen Cox, CEO and Co-Founder of InVera Medical. "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."
The company, founded in 2018, focuses on creating catheter-based solutions for vein disease with a patient-focused and scientific approach to device innovation. The technology aims to expand the fastest growing non-thermal segment of the superficial venous reflux market.