FIND RELIEF FROM VARICOSE VEINS. VenaSeal Sapheon Closure System
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1 FIND RELIEF FROM VARICOSE VEINS VenaSeal Sapheon Closure System
2 UNDERSTAND Varicose veins may be a sign of something more severe. Your doctor can help you understand if you have this condition. may cause the following signs and symptoms in your legs 1 : Varicose veins Aching Swelling Cramping Heaviness or tiredness Itching Open skin sores Restlessness
3 VENOUS ANATOMY FEMORAL VEIN GREAT SAPHENOUS VEIN SMALL SAPHENOUS VEIN NORMAL VEIN Valves ensure blood DISEASED VEIN Valves that cannot close allow blood to drain and pool 1 Criqui, M. H., Denenberg, J. O., Langer, R. D., Kaplan, R. M., & Fronek, A. (2013). Epidemiology of Chronic Peripheral Venous Disease. In J. J. Bergan & N. Bunke-Paquette (Eds.), The Vein Book (pp ). New York, NY: Oxford University Press.
4 TREAT CLINICAL TRIAL EXPERIENCE Treating the diseased vein improves overall blood compression stockings alone may improve blood diseased vein may be necessary to improve blood blood to nearby healthy veins. Your doctor can help you decide which treatment option is best for you. Three clinical studies demonstrated results that support the clinical VenaSeal system. 1,2,3 immediately and stayed closed. Blood symptoms improved. In the US study, The VenaSeal system and thermal energy (radiofrequency ablation; RFA) treatments had similar clinical results (at 3 months, 98.9% closure for the VenaSeal system and 95.4% closure for thermal energy). 1* 97.2% of veins remained closed at 12 months after treatment with the VenaSeal system. 1 VENASEAL CLOSURE SYSTEM The VenaSeal system showed improvement in vein. The system delivers a small amount of a specially formulated medical adhesive to the diseased vein. The adhesive seals the vein and blood is rerouted through nearby healthy veins. Phlebitis occurred more frequently in VenaSeal-treated subjects compared to RFA-treated subjects. Phlebitis is a treatments, including the VenaSeal system and RFA, and they typically occurred within 1 Please see the Potential Risk section for more information.
5 REDUCES DISCOMFORT AND RECOVERY TIME THERMAL ENERGY: THE TRADITIONAL TREATMENT OPTION Heat has shown to close the vein Multiple needle sticks of numbing medicine VENASEAL CLOSURE SYSTEM: AN INNOVATIVE TREATMENT OPTION Adhesive has shown to seal the vein Only one needle stick of numbing medicine Compression stockings required after the procedure No compression stockings after the procedure ** In comparison, patients treated with the VenaSeal system experience less pain and bruising. 1 1 Morrison N. et al, Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). Journal of Vascular Surgery saphenous veins. Journal of Vascular Surgery incompetence. Phlebology: published online 30 March 2014.
6 FAQ What can I expect of the VenaSeal procedure? Before the Procedure: You will have an ultrasound imaging exam of the leg that is to be treated. This exam is important for assessing the During the Procedure: Your doctor can discuss the procedure with you. A brief summary of what to expect is below: You may feel some minor pain or stinging with a needle stick to numb the site where the doctor will access your vein. Once the area is numb, your doctor will insert the catheter (i.e., a small hollow tube) into your leg. You may feel some pressure from the placement of the catheter. diseased vein to deliver small amounts of the medical adhesive. You may feel some mild sensation of pulling or tugging. Ultrasound will be used during the procedure to guide and position the catheter. After treatment, the catheter is removed and a bandage placed over the puncture site. After the Procedure: You will be taken to the recovery area to rest. Your doctor will discuss with you what observations will be performed following treatment. When will my symptoms improve? Thus, symptoms may improve as soon as the diseased vein is closed. When can I return to normal activity? The VenaSeal procedure is designed to reduce recovery time. Many patients return to normal activity immediately after the procedure. Your doctor can help you determine when you can return to normal activity. Is the VenaSeal procedure painful? Most patients feel little, if any, pain during the outpatient procedure. 1 Is there bruising after the VenaSeal procedure? Most patients report little-to-no bruising after the VenaSeal procedure. 1 What happens to the VenaSeal adhesive? Only a very small amount of VenaSeal adhesive is used to close the vein. Your body will naturally absorb the adhesive over time. thermal energy procedures? The VenaSeal procedure uses an adhesive to close the close the vein. The intense heat requires a large volume of numbing medicine, which is injected through many needle sticks. The injections may cause pain and bruising after the procedure. Is the VenaSeal procedure covered by insurance? As with any procedure, insurance coverage may vary. For more information, please contact your insurance provider.
7 The VenaSeal Procedure may not be right for everyone Your doctor can help you decide if the VenaSeal procedure is right for you. The VenaSeal procedure is contraindicated for individuals with any of the following conditions: Previous hypersensitivity reactions to the VenaSeal adhesive or cyanoacrylates Potential risks The VenaSeal procedure is minimally invasive and catheter-based. As such, it may involve the following risks. Your doctor can help you understand these risks. Allergic reaction to the VenaSeal adhesive Bleeding from the access site Deep vein thrombosis (i.e., blood clot in the deep vein system) Edema (i.e., swelling) in the treated leg Hematoma (i.e., the collection of blood outside of a vessel) Hyperpigmentation (i.e., darkening of the skin) Infection at the access site Pain Paresthesia (i.e., a feeling of tingling, pricking, numbness or burning) Pulmonary embolism (i.e., blockage of an artery in the lungs) Urticaria (i.e., hives) or ulceration may occur at the site of injection Vascular rupture and perforation Visible scarring The VenaSeal Sapheon Closure System (SCS) is intended for the permanent, complete, endovascular adhesive closure of the 1 Morrison N. et al, Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). Journal of Vascular Surgery
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FIND RELIEF FROM VARICOSE VEINS. VenaSeal Closure System
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