We are a clinical-stage medical device company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of venous disease. Chronic Venous Insufficiency (CVI) occurs when the valves inside the veins of your leg do not function properly, causing blood to flow backward and pool in the lower leg, leading to elevated venous pressure inside the leg veins. The purpose of the SAVVE study is to determine whether the VenoValve® is a safe and effective treatment for patients with severe, deep venous CVI. The VenoValve is surgically implanted into a vein via a 5 to 6-inch incision in the upper thigh. The procedure should take less than an hour and the patient will receive general or regional anesthesia. After the VenoValve procedure, the patient will stay in the hospital for one night for patient comfort. The patient will be asked to see their doctor 7 days, 30 days, 90 days, 180 days, and 365 days after the VenoValve procedure. The VenoValve is designed to be a permanent implant and the patient should continue to see their doctor once a year for at least the next 4 years. FIRST-IN-HUMAN STUDY: Am I the first patient to receive a VenoValve? Eleven patients have already received the VenoValve as part of a small clinical trial. Safety incidences were minor, the disease severity (VCSS scores) improved an average of 56%, and pain (VAS scores) improved an average of 76%, compared to pre-VenoValve levels. The patients also experienced a significant improvement in their quality of life and were able to resume pre-CVI activities. The VenoValve stopped working after one patient stopped taking their prescribed medication.
