#Ireland #Galway #InVera Medical #Infusion Device #Vein Closure

InVera Medical's Transformative Infusion Device Results

InVera Medical, an innovative medical device firm based in Ireland, has recently shared promising results from a one-year pilot trial of its unique InVera Infusion Device. This device, engineered specifically for the treatment of Chronic Venous Disease (CVD), has emerged as a pioneering solution that significantly enhances patient outcomes while minimizing procedural discomfort. The findings emphasize the device's capability to achieve a vein closure rate of 90%, coupled with meaningful improvements in patients' quality of life.

Pilot Study Highlights

In the pilot study, the InVera Infusion Device was applied to a group of ten patients diagnosed with CVD, specifically those classified within CEAP stages C2 to C4. These individuals were suffering from issues related to the Great Saphenous Vein (GSV) and required ablation procedures due to abnormal reflux. Under strict study protocols, which intentionally limited additional procedures or tributary vein management, researchers meticulously assessed outcomes at twelve months post-treatment.

The study yielded impressive results: 90% of participants demonstrated complete closure of the GSV segments via duplex ultrasound evaluation, indicating sustained vein closure. Furthermore, patients experienced remarkable improvements in their reported symptoms as measured by the HASTI questionnaire. The results indicated a significant reduction in symptom severity—with scores dropping from an average of 7.0 to 1.8 (p=0.03) over the year. Similarly, the revised Venous Clinical Severity Score (rVCSS) also improved considerably, showcasing a 38% reduction in clinical symptoms over the same period.

Throughout the follow-up, the study noted no serious adverse events, a critical factor in assessing the safety of medical treatments. Notably, there were no occurrences of deep vein thrombosis (DVT), addressing one of the primary safety concerns prevalent in traditional venous procedures.

A Safer, Non-Thermal Approach

One of the significant advantages of the InVera Infusion Device is its non-thermal approach to treating vein diseases. Unlike conventional thermal ablation techniques, which can necessitate painful injections and risk nerve damage, the InVera device employs a gentle method that avoids these major complications. This innovative technology utilizes a specially designed 5Fr catheter that creates micropores in the inner vein wall, allowing for an effective sclerosant delivery deep into the vessel layers.

As a result, the InVera Infusion Device not only enhances the probability of permanent vein closure but also ensures the patient experience is considerably less invasive—only requiring a minor local anesthetic at the access site rather than multiple painful injections.

Recognition Among Medical Experts

Dr. Lowell Kabnick, the head of InVera's Medical Advisory Board and a respected figure in the field, presented these groundbreaking findings at the International Charing Cross Symposium in London. His commentary highlighted the robustness of the results, stressing the promising role of the InVera Infusion Device in transforming the clinical management of chronic venous diseases.

Moreover, Professor Imre Bihari, principal investigator of the study, also noted how the procedure was well-tolerated by patients, adding that the device's intuitive design simplifies its integration into clinical practice. The study results have sparked enthusiasm in the medical community, not only for their immediate implications but for the future comparative studies aimed at validating the device's role further.

Regulatory Achievements and Future Directions

The compelling data aligns with InVera Medical's recent achievements in regulatory milestones, including FDA 510(k) clearance and CE Mark approval for the Infusion Device in early 2026. These certifications pave the way for a limited market release in select centers across Europe and the U.S., heralding a new era in the management of Chronic Venous Disease.

The commitment of InVera Medical to innovate and improve patient care in the field of vein disease is evident from these results. The InVera Infusion Device opens new avenues for healthcare providers and patients alike, promising enhanced outcomes, increased satisfaction, and a significant leap forward in managing chronic venous conditions effectively.