Venous Reflux Disease and Current Treatment Modalities VN20-03-B 10/04

Leg Vein Anatomy Your legs are made up of a network of veins and vessels that carry blood back to the heart The venous system is comprised of: –Deep veins –Superficial veins VN20-03-B 10/04

Leg Vein Anatomy Perforating veins connect the deep system with the superficial system They pass through the deep fascia at mid- thigh, knee and ankle VN20-03-B 10/04

Venous Reflux Disease 1.Vein valves become damaged or diseased, resulting in vein valve failure 2.Reflux or backward flow in the veins occurs 3.Pooling of blood causes pressure in leg veins 4.Increased pressure may cause surface veins to become varicose Valve Open Valve Closed Leaky Valve Dilated Vein Normal Vein Heart Foot VN20-03-B 10/04

Patient Demographics It is estimated that in America, 72% of women and 42% of men will experience varicose veins by the time they are in their 60s Prevalence is highly correlated to age and gender Risk factors: –Multiple pregnancies –Family history –Obesity –Standing profession VN20-03-B 10/04

Symptoms Approximately 25 million Americans suffer from venous reflux Common symptoms of this progressive condition include: –Varicose veins –Pain –Swollen limbs –Leg heaviness and fatigue –Skin changes and skin ulcers VN20-03-B 10/04

Conservative Treatments Leg elevation Compression stockings Unna boot NOTE: Conservative treatments often fail due to poor patient compliance VN20-03-B 10/04

Adjunctive Procedures Sclerotherapy External lasers and intensed pulsed light Used to treat small superficial or “spider” veins Image courtesy of Robert A. Weiss, MD VN20-03-B 10/04

Adjunctive Procedures Phlebectomy –Removal of diseased veins through a series of small incisions and use of specialized hooks to treat visible varicose veins Images courtesy of Kenneth Harper, MD VN20-03-B 10/04

The Closure ® Procedure The VNUS Closure procedure is a minimally invasive treatment alternative to vein stripping VN20-03-B 10/04

Procedural Highlights Relief of symptoms Resume normal activities within 1-2 days Outpatient procedure Local or general anesthesia Good cosmetic outcome with minimal to no scarring, bruising or swelling VN20-03-B 10/04

Proven Benefits Clinical data demonstrates long-term patient symptom relief: 1 Merchant R. Long term outcome of endovascular radiofrequency obliteration for treatment of primary chronic venous insufficiency- five years follow-up of a multi-centre prospective study. Presented at 18 th annual meeting of European Society for Vascular Surgery September 2004; Innsbruck, Austria. VN20-03-B 10/04 VNUS Clinical Registry Patient Symptom Relief

The Closure Procedure Results One week post-treatment* Pre-treatment Image courtesy of Robert Merchant, MD *Individual results may vary Photos courtesy of Michael A. Vasquez, MD, F.A.C.S. VN20-03-B 10/04

Patient Satisfaction 98% of patients who have undergone the Closure procedure are willing to recommend it to a friend or family member 2 The Closure procedure is covered by most insurance providers 2 Weiss RA, et al: Controlled radiofrequency endovenous occlusion using a unique radiofrequency catheter under duplex guidance to eliminate saphenous varicose vein reflux: a 2-year follow-up. Dermatol Surg 2002; 28: VN20-03-B 10/04

Safety Summary Indication: The Closure System is intended for endovascular coagulation of blood vessels in patients with superficial venous reflux. Contraindications: Patients with a thrombus in the vein segment to be treated. Potential Risks & Complications: Potential complications include, but are not limited to, the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, paresthesia, skin burns. VN20-03-B 10/04