Surgical Anti-reflux Venous Valve Endoprosthesis
Ongoing Pivotal Study to Evaluate VenoValve® for the Treatment of Chronic Venous Insufficiency
What is the SAVVE Study?
Chronic Venous Insufficiency (CVI) occurs when the valves inside the veins of your leg do not function properly, causing blood to flow backwards 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.
Prospective, Non-Blinded, Single Arm, Multi-Center Study
What is the VenoValve Procedure?
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.
Patients with severe CVI who experience symptoms including leg swelling, discoloration, heaviness, itchiness, pain, and open sores that are difficult to heal, may be candidates for the SAVVE study. Learn more at the study website.
Male and Female
Chronic, axial deep
venous reflux secondary
to previous deep venous thrombosis or primary reflux
Failed at least 3 months of standard care including compression therapy, and in C6 patients, wound care
Creating Centers of Excellence Around Highly Populated Areas
Chronic Venous Insufficiency