VenaSeal™ Closure System

What is venous reflux disease?

Healthy leg veins have valves that keep blood flowing to the heart. Venous reflux disease, also known as chronic venous disease, develops when the valves stop working properly and allow blood to flow backward (i.e., reflux) and pool in the lower leg veins. If venous reflux disease is left untreated, symptoms can worsen over time. As a result, vein valves will not close properly, leading to signs and symptoms such as:

• Varicose veins
• Aching
• Swelling
• Cramping
• Heaviness or tiredness
• Itching
• Restlessness
• Open skin sores

How prevalent is venous reflux disease?

• More than 190 million people have CVI or varicose veins globally. In the U.S., more than 30 million Americans suffer from varicose veins, or the more serious form of venous disease called chronic venous insufficiency (CVI), yet the majority remains undiagnosed and untreated.
• Varicose veins, a common symptom of venous reflux disease, can affect up to 40 percent of adults.
• Varicose veins are more common in those who are overweight, and in women who have had more than two pregnancies.
• Women usually have multiple risk factors for the development of varicose veins. In fact, varicose veins are most common in women (75 percent of those diagnosed) than in men (25 percent of those diagnosed).
• Up to 55 percent of American women may be affected by varicose veins in their lifetime.
• It is common for varicose veins to become more prominent during pregnancy and worsen with successive pregnancies.

FREQUENTLY ASKED QUESTIONS

How is venous reflux disease treated? Venous reflux disease treatment aims to reduce or stop the backward flow of blood. Treating the diseased vein improves overall blood flow and relieves symptoms. For some patients, compression stockings alone may improve blood flow. For other patients, closing or removing the diseased vein may be necessary to improve blood flow. Closing or removing the diseased vein directs blood to nearby healthy veins.

What is the VenaSeal™ closure system? The VenaSeal™ closure system is a non-thermal, nontumescent, non-sclerosant procedure that uses an advanced medical adhesive to close the diseased vein.

What does it treat? The VenaSeal™ closure system treats symptomatic venous reflux disease in the lower extremity superficial truncal veins, often the underlying cause of painful varicose veins.

How does it work? During the procedure, a trained clinician fills a syringe with the medical adhesive, which is inserted into the VenaSeal™ closure system’s dispensing gun that is attached to a catheter. The catheter is advanced into the diseased vein under ultrasound guidance. The catheter is placed in specific areas along the diseased vein and the clinician conducts a series of trigger pulls to deliver the medical adhesive. Compression is applied to the leg during the procedure.

Is there clinical data to support the use of the VenaSeal™ closure system? The VenaSeal™ closure system has been shown to be effective in three clinical studies, with demonstrated safety and high closure rates.

• The VeClose pivotal study demonstrates safety and efficacy of the VenaSeal™ closure system with closure rates of 94.4 percent at 36 months.
• Results from the European Sapheon Closure System Observational ProspectivE (eSCOPE) study as presented in the Journal of Vascular Surgery demonstrate a cumulative closure rate of 88.5 percent and improvement in quality of life scores at 36 months.
• Closure rates in the Feasibility Study were 94.7 percent at 36 months.11 How does the VenaSeal™ closure system differ from thermal energy procedures? The VenaSeal™ closure system uses an adhesive to close the vein. Thermal energy uses heat to close the vein. The intense heat requires a large volume of dilute numbing medicine, which is injected through multiple needle sticks. The injections may cause pain and bruising after the procedure.

How quickly can patients return to normal activities post procedure? The VenaSeal™ closure system procedure is designed to minimize patient discomfort and reduce recovery time. After the procedure, a small bandage will be placed at the access site. Patients are able to rapidly return to normal activities. Additionally, patients have reported minimal bruising following the VenaSeal™ closure system procedure.

Is treatment with the VenaSeal™ closure system suitable for everyone? The VenaSeal™ closure system should not be used in patients who have a known hypersensitivity to the VenaSeal™ closure system’s adhesive, acute inflammation of the veins due to blood clots, or acute whole-body infection. Adverse events observed in the VenaSeal™ closure system trials—and generally associated with treatments of this condition—included vein inflammation (phlebitis) and burning or tingling (paresthesia) in the treatment zone. A vein specialist can tell you if the VenaSeal™ closure system is the right option for your situation.

What happens to the treated vein left behind in the leg? Don’t I need it? Faulty valves interfere with the normal return of blood through the venous system. Closing these diseased veins helps to re-route the blood through nearby veins, improving circulation and relieving most symptoms. Only a very small amount of VenaSeal™ adhesive is used to close the vein. Your body will naturally create scar tissue around the adhesive over time to keep the vessel permanently closed.

Is the VenaSeal™ closure system procedure covered by insurance? As with any procedure, insurance coverage may vary. Those interested in the VenaSeal™ closure system should contact their insurance provider for more information.