Endovenous Radiofrequency Ablation of the Saphenous Vein The VNUS Closure Procedure

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1 Endovenous Radiofrequency Ablation of the Saphenous Vein The VNUS Closure Procedure VN20-86-E 4/09

2 25 Million people suffer from venous reflux disease, the underlying cause for most varicose veins VNUS Closure is the minimally invasive treatment for the medically indicated treatment of varicose veins Images courtesy of Paul McNeill, MD and Rajabrata Sarkar, MD

3 Prevalence and Etiology of Venous Insufficiency Venous reflux disease is 2x more prevalent than coronary heart disease (CHD) and 5x more prevalent than peripheral arterial disease (PAD) 1 Venous Reflux Disease Coronary Heart Disease Peripheral Arterial Disease Congestive Heart Failure Stroke Annual U.S. Incidence U.S. Prevalence Cardiac Arrhythmias Heart Valve Disease Millions

4 Prevalence and Etiology of Venous Insufficiency Of the estimated 25 million people with symptomatic superficial venous reflux 1 : Only 1.7 million seek treatment annually 2 Over 23 million go untreated Prevalence by Age and Gender 3,4 Age Female Male % 1% % 24% % 43%

5 Venous System Venous blood flows from the capillaries to the heart Flow occurs against gravity Muscular compression of the veins Negative intrathoracic pressure Calf muscle pump Low flow, low pressure system Deep femoral v. Perforating v. Femoral v. Popliteal v. Small saphenous v. Great saphenous v. Perforating v. Image source: Fundamentals of Phlebology: Venous Disease for Clinicians. Illustration by Linda S. Nye. American College of Phlebology 2004.

6 Pathophysiology of Venous Insufficiency

7 Risk Factors and Symptoms of Venous Insufficiency Risk factors of venous insufficiency: Gender Age Heredity Pregnancy Standing occupation Obesity Prior injury or surgery Sedentary lifestyle Symptoms of venous insufficiency: Leg pain, aching, or cramping Burning or itching of the skin Leg or ankle swelling Heavy feeling in legs Skin discoloration or texture changes Open wounds or sores Restless legs Varicose Veins

8 Manifestations of Venous Insufficiency Superficial venous reflux is progressive and if left untreated, may worsen over time. Below are manifestations of the disease. 5 Varicose Veins Swollen Legs Skin Changes Skin Ulcers 20+ million 2 to 6 million 500,000 Photos courtesy of Rajabrata Sarkar, MD, PhD.

9 CEAP Classifications Clinical Classifications of Venous Insufficiency (CEAP) Class 0 - No visible or palpable signs of venous disease Class 1 - Telangiectasias or reticular veins Class 2 - Varicose veins Class 3 - Edema Class 4 - Skin changes (4a) Skin changes including pigmentation or venous eczema (4b) Skin changes with lipodermatosclerosis Class 5 - Healed venous ulceration Class 6 - Active venous ulceration

10 The VNUS Closure System The VNUS Closure System is a minimally invasive treatment alternative for patients with symptomatic superficial venous reflux and varicose veins Using a catheter-based approach, the VNUS ClosureFAST catheter delivers radiofrequency (RF) energy to the vein wall RF energy creates conductive heating that contracts the vein wall collagen, thereby occluding the vein

11 VNUS Closure Procedure using the ClosureFAST Catheter

12 Efficacy of the ClosureFAST Catheter The ClosureFAST catheter ablates the vein in 7cm segments with 20-second treatment cycles, resulting in vein shrinkage and occlusion. Interim data from a multicenter prospective study have shown 97.4% vein occlusion 1 year post-treatment. 6

13 Radiofrequency Ablation Procedure Video

14 Ablation Comparison (simulation in beef liver)

15 Post-Procedure Instructions Ambulate frequently, a minimum of 30 minutes daily Avoid heavy/strenuous exercise for a few days Avoid prolonged sitting or standing Wear compression stockings for up to 2 weeks Patient should return for duplex scan within 72 hours VNUS Closure Visual Results Pre-treatment One week post-treatment* *Individual results may vary

16 RECOVERY Trial 7 A Prospective, Multi-Center, Randomized Study Purpose - Determine if patient recovery and other short term outcomes are different between radiofrequency and laser treatment Six center, single-blinded randomized trial of ClosureFAST vs. Endovenous Laser 69 patients; 87 limbs treated (46 CLF; 41 EVL) Patient follow up at 2, 7, 14, and 30 days after treatment

17 RECOVERY Trial 7 : Pain A Prospective, Multi-Center, Randomized Study 10. Overall Maximum Pain Score (0 none to 10 max) p < ClosureFAST 1 Laser

18 RECOVERY Trial 7 : Ecchymosis A Prospective, Multi-Center, Randomized Study Moderate to Severe Ecchymosis (Bruising) After Treatment Moderate to severe ecchymosis is defined as bruising over greater than 25% of the treated surface area 100% 75% 50% p < % 25% 0% 2.2% ClosureFAST 1 Laser

19 RECOVERY Trial 7 : Ecchymosis A Prospective, Multi-Center, Randomized Study Presence of Any Ecchymosis (Post Procedure) 100% 80.5% 74.3% 66.7% 75% 33.0% 35.0% 50% 18.6% 22.5% 25% 2.2% 0% 2 Days ClosureFAST 7 Days 14 Days Laser30 Days

20 RECOVERY Trial 7 : Conclusion A Prospective, Multi-Center, Randomized Study Compared to laser, RF treatment with ClosureFAST produced significantly Less pain p < Less tenderness p = Less bruising p < Fewer adverse events p = 0.021

21 ClosureFAST Catheter Indication: The ClosureFAST Catheter is intended for endovascular coagulation of blood vessels in patients with superficial venous reflux Contraindications: Patients with 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, adjacent nerve injury, skin burns, deep vein thrombosis

22 Venous leg ulcers Venous Ulcers Treat the source, not just the symptom

23 Perforating Veins and Reflux Perforator valves maintain oneway flow from superficial to deep veins Perforator valve failure causes: Higher venous pressure and GSV/branch dilation Increasing pressure results in GSV valve failure Additional vein branches become varicose Further GSV incompetence and dilation

24 Systemic Reflux in Venous Ulceration Sources of Reflux in Venous Ulcer Patients 8 Superficial Perforating Deep 79% 63% 50% Incompetent perforators found in 63% of venous ulcer patients Photos courtesy of Steven A. Kaufman, MD. Comprehensive care treats all sources of reflux

25 VNUS ClosureRFS VNUS ClosureRFS Benefits: Minimally invasive Outpatient procedure Quick patient recovery Only device cleared by the FDA for the endovenous ablation of incompetent perforator veins Click graphic to play video

26 Venous Ulcer Patient Outcomes Treating the underlying cause of venous ulceration results in improved clinical outcomes Treating both the superficial and perforator hypertension results in: Faster ulcer healing time Lower ulcer recurrence rate than with compression therapy alone 9,10

27 References 1. American Heart Association, SIR, Brand et al. The Epidemiology of Varicose Veins: The Framingham Study 2. US Markets for Varicose Vein Treatment Devices 2006, Millennium Research Group Coon WW, Willis PW, Keller JB: Venous thromboembolism and other venous disease in the Tecumseh Community Health Study Circulation 1973; 48: Barron HC, Ross BA. Varicose Veins: A guide to prevention and treatment. NY, NY: Facts on File, Inc. [An Infobase Holdings Company]; 1995;vii. 5. White JV, Ryjewski C. Chronic venous insufficiency. Perspect Vasc Surg Endovasc Ther 2005;17: Dietzek A, Two-Year Follow-Up Data From A Prospective, Multicenter Study Of The Efficacy Of The ClosureFAST Catheter, 35th Annual Veith Symposium. November 19, New York. 7. Alameida JI. Lessons Learned After 2000 Endovenous Ablations. 34 th Veith Symposium. Nov 14-18, New York 8. Hanrahn L. et al. Distribution of valvular incompetence in patients with venous stasis ulceration. JVS 13,6, June Jamie R Barwell, Colin E Davies, Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomized controlled trial,the LANCET, Vol 363, June Nelzen O. Fransson I. True long-term healing and recurrence of venous leg ulcers following SEPS combined with superficial venous surgery: a prospective study. Eur J Vasc Endovasc Surg 34, (2007)

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