InVera Medical recently announced 12-month results from its pilot clinical study of the InVera infusion device, designed to treat chronic venous disease (CVD). The results, presented by Lowell Kabnick (Kabnick Vein Center, Morristown, USA) at the 2026 Charing Cross (CX) Symposium (21–23 April, London, UK), demonstrated statistically significant improvements in patient symptoms, high procedural efficacy, and an “excellent” safety profile, a press release reveals.
The pilot study enrolled 10 patients with CVD (CEAP classification C2-C4) requiring ablation of the great saphenous vein (GSV) due to abnormal reflux, who were followed for one year. The study used a strict protocol that prohibited adjunctive procedures or tributary vein management to minimise confounding factors.
At 12 months post-procedure:
- 90% of patients demonstrated closure of GSV segments based on duplex ultrasound criteria assessment.
- The vein ultrasound response remained stable in these patients between six-month and 12-month follow-up, indicating durable vein closure following the procedure.
- One patient experienced vein recanalisation at eight weeks.
- Patients showed statistically significant improvements across multiple measures.
- Patient-reported symptoms, measured with the HASTI (Heaviness, Achiness, Swelling, Throbbing and Itching) questionnaire, improved by 74%, from a baseline mean of 7 to 1.8 at 12 months (p=0.03).
- Clinical evaluation using the revised Venous Clinical Severity Score (rVCSS), improved by 38% from a baseline mean of 2.9 to 1.8 at 12 months (p=0.03).
- Throughout the 12-month follow-up period, there were no serious adverse events and no cases of deep vein thrombosis (DVT).
- As the InVera device is non-thermal, there were no instances of complications associated with thermal ablation procedures, such as skin burns, nerve damage, or other thermal-related injuries.
- Technical procedural success, involving preparation of the inner vein lining and subsequent sclerosant delivery to sub-endothelial layers with the InVera infusion device, was achieved in all cases.
“These 12-month results demonstrate consistent procedural performance and a favourable safety profile,” said Kabnick, head of InVera’s medical advisory board, at CX 2026. “The durable response seen on ultrasound is particularly encouraging for a non-thermal technique. I am excited to present this data at the internationally renowned Charing Cross Symposium today and to be involved in the broader comparative studies planned to establish the InVera infusion device’s role in clinical practice.”
“The InVera infusion device takes an intuitive approach, making it easy to use and incorporate into clinical practice,” said Imre Bihari (Semmelweis University, Budapest, Hungary), principal investigator of the InVera infusion device pilot study. “Patients were comfortable throughout the procedure and did not require tumescent anaesthesia. I was delighted to see the strength of the long-term ultrasound outcomes, and I look forward to seeing the device progress into larger clinical studies.”
