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

Primary
Safety Endpoint

30 DAYS

Primary
Efficacy Endpoint

6 MONTHS

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.

Eligibility

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

Adult Patients

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

If you are interested in participating in the ongoing SAVVE study, please contact your physician or register for more information at the study website.

 

 

Chronic Venous Insufficiency

VenoValve®

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