Chronic Venous Insufficiency (CVI)
Insufficient blood is returned to the heart and lungs due to damaged valves in the veins of the leg.
SAVVE Clinical Study
Once blood has been circulated through the lower body, the calf and leg muscles serve as a pump to squeeze the blood up the veins of the leg, against gravity, and through the series of one-way valves. In a healthy person, the venous system acts in a similar manner to locks and dams along a river. When blood propelled by the calf muscle reaches a valve, the valve opens, the blood passes through, the valve is supposed to close, and the blood moves on to the next valve much like a climber who ascends the rungs of a ladder.
Normally Functioning Vein
In the leg, a series of one-way valves help move blood up the leg, against gravity, and back up to the heart.
Damaged valves are not able to move blood up the leg, resulting in reflux, blood pooling, venous hypertension, and ulceration.
When valves in the veins of the legs become incompetent, they begin to leak and, if destroyed, they do not close at all. If a rung were to break while climbing a ladder, gravity takes over and the climber falls to the ground. The same thing happens with blood in the veins of the leg when valves fail. The calf muscle pushes the blood up the veins, but if the valves don’t hold, gravity takes over and the blood flows back in the wrong direction (reflux) and pools in the lower leg and ankle area. With nowhere to go, the pooling blood causes increased pressure inside of the veins of the leg (venous hypertension).
CVI Leads to:
Reflux – blood flows in the wrong direction
Blood pooling in the lower leg
CVI Patients Need an Effective Treatment
Venous hypertension causes the leg to swell, and blood vessels to break, resulting in discoloration, pain, claudication, and the breakdown of the skin leading to venous ulcers (open sores) which are very difficult to heal. Everyday tasks such as bathing, sleeping, and household chores become extremely difficult for CVI sufferers and studies have shown that the quality of the lives of CVI sufferers can be worse than for patients with osteoarthritis, angina, and chronic lung disease.1
Over the years, many attempts have been made to repair or replace incompetent valves in the veins of the leg, with little success. Other treatment options include compression garments, and leg elevation. While compression garments and leg elevation focus on trying to empty blood from the veins, they do nothing to repair or replace the cause of the disease, which is incompetent valves and venous hypertension.
SAVVE Clinical Study
- Kahn SR, Comerota AJ, Cushman M, Evans NS, Ginsberg JS, Goldenberg NA, Gupta DK, Prandoni P, Vedantham S, Walsh ME, Weitz JI; on behalf of the American Heart Association Council on Peripheral Vascular Disease, Council on Clinical Cardiology, and Council on Cardiovascular and Stroke Nursing. The post thrombotic syndrome: evidence-based prevention, diagnosis, and treatment strategies: a scientific statement from the American Heart Association. Circulation. 2014;130:1636–1661
- Yost, Mary, The Sage Group, Chronic Venous Disease, Epidemiology, Costs, and Consequences, 2016
- Sachdev, Ulka, et. al. Suppressed Networks of Inflammatory Mediators Characterize Chronic Venous Insufficiency, Journal of Vascular Surgery: Venous and Lymphatic Disorders, May 2018
The VenoValve® and enVVe™ are investigational medical devices currently in development. Neither device is approved or cleared for any indication in any market. The VenoValve® is only available for use in the United States in pre-market clinical studies.