Endovenous Radiofrequency Ablation

of the Saphenous Vein

The VNUS Closure® Procedure

VN20-86-E 4/09

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

Prevalence and Etiology of Venous Insufficiency

0 5 10 15 20 25

Heart Valve Disease

Cardiac Arrhythmias

Stroke

Congestive Heart Failure

Peripheral Arterial Disease

Coronary Heart Disease

Venous Reflux Disease

Annual U.S. Incidence

U.S. Prevalence

Millions

Venous reflux disease is 2x more prevalent than coronary heart disease (CHD) and 5x more prevalent than peripheral arterial disease (PAD)1

Prevalence and Etiology of Venous Insufficiency

Age Female Male

20 - 29 8% 1%

40 - 49 41% 24%

60 - 69 72% 43%

Prevalence by Age and Gender3,4

Of the estimated 25 million people with symptomatic superficial venous reflux1 :

• Only 1.7 million seek treatment annually2

• Over 23 million go untreated

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.

Femoral v.

Popliteal v.

Small saphenous v.

Great saphenous v.

Perforating v.

Perforating v.

Image source: Fundamentals of Phlebology: Venous Disease for Clinicians. Illustration by Linda S. Nye. American College of Phlebology 2004.

Pathophysiology of Venous Insufficiency

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

20+ million 2 to 6 million

Skin Ulcers

500,000

Manifestations of Venous Insufficiency

Superficial venous reflux is progressive and if left untreated, may worsen over time. Below are manifestations of the disease.5

Photos courtesy of Rajabrata Sarkar, MD, PhD.

Swollen Legs Skin Changes Varicose Veins

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

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

VNUS Closure® Procedure using the ClosureFAST™ Catheter

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

Radiofrequency AblationProcedure Video

Ablation Comparison(simulation in beef liver)

VNUS Closure® Visual Results

One week post-treatment* Pre-treatment*Individual results may vary

• 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

Post-Procedure Instructions

RECOVERY Trial7

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

Overall Maximum Pain Score (0 none to 10 max)Overall Maximum Pain Score (0 none to 10 max)

RECOVERY Trial7: PainA Prospective, Multi-Center, Randomized Study

0

1

2

3

4

5

6

7

8

9

10

ClosureFAST Laser

p < 0.0001

2

4

RECOVERY Trial7: EcchymosisA Prospective, Multi-Center, Randomized Study

0%

10%

20%

30%

40%50%

60%

70%

80%

90%

100%

ClosureFAST Laser

p < 0.0001

Moderate to Severe Ecchymosis (Bruising) After TreatmentModerate to Severe Ecchymosis (Bruising) After TreatmentModerate to severe ecchymosis is defined as bruising over greater than 25% of the treated surface area

2.2%

51.3%

RECOVERY Trial7: EcchymosisA Prospective, Multi-Center, Randomized Study

Presence of Any Ecchymosis (Post Procedure)Presence of Any Ecchymosis (Post Procedure)

0%

20%

40%

60%

80%

100%

2 Days 7 Days 14 Days 30 Days

ClosureFAST Laser

33.0%

80.5%

35.0%

74.3%

18.6%

66.7%

2.2%

22.5%

RECOVERY Trial7: Conclusion

A Prospective, Multi-Center, Randomized Study

Compared to laser, RF treatment with ClosureFAST produced significantly

– Less pain p < 0.0001

– Less tenderness p = 0.0008

– Less bruising p < 0.0001

– Fewer adverse events p = 0.021

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

Perforating Veins and Reflux

• Perforator valves maintain one-way 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

Systemic Reflux in Venous Ulceration

Incompetent perforators found in 63% of venous ulcer patients

Comprehensive care treats all sources of refluxPhotos courtesy of Steven A. Kaufman, MD.

Sources of Reflux in

Venous Ulcer Patients8

Superficial Perforating Deep

79% 63% 50%

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

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 alone9,10

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 2005. 3. Coon WW, Willis PW, Keller JB: Venous thromboembolism and other venous disease in the

Tecumseh Community Health Study Circulation 1973; 48:839-846. 4. 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;17:319-276. 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, 2008. New York.

7. Alameida JI. Lessons Learned After 2000 Endovenous Ablations. 34 th Veith Symposium. Nov 14-18, 2007. New York

8. Hanrahn L. et al. Distribution of valvular incompetence in patients with venous stasis ulceration. JVS 13,6, 805-812 June 1991

9. 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 04

10. 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, 605-612 (2007)