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
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 Annual U.S. Incidence

U.S. Prevalence
Stroke

Cardiac Arrhythmias

Heart Valve Disease

0 5 10 15 20 25
Millions
 Prevalence and Etiology of
Venous Insufficiency

Of the estimated 25 million people with symptomatic superficial

venous reflux1 :
• Only 1.7 million seek treatment annually2
• Over 23 million go untreated

Prevalence by Age and Gender3,4

Age Female Male

20 - 29 8% 1%
40 - 49 41% 24%
60 - 69 72% 43%
 Venous System

• Venous blood flows from the

capillaries to the heart Deep femoral v.
Perforating v.
• Flow occurs against gravity Femoral v.

– Muscular compression of the

veins Popliteal v.
– Negative intrathoracic
pressure Small saphenous
v.
– Calf muscle pump Great saphenous
v. Perforating v.
• Low flow, low pressure system

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: Symptoms of venous insufficiency:

• Gender • Leg pain, aching, or cramping

• Age • Burning or itching of the skin

• Heredity • Leg or ankle swelling

• Pregnancy • “Heavy” feeling in legs

• Standing occupation • Skin discoloration or texture changes

• Obesity • Open wounds or sores

• Prior injury or surgery • Restless legs

• Sedentary lifestyle • Varicose Veins

 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.

 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 Ablation
Procedure Video
Ablation Comparison
(simulation in beef liver)
 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
 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
 RECOVERY Trial7: Pain
A Prospective, Multi-Center, Randomized Study

Overall Maximum Pain Score (0 none to 10 max)

10
9
8
7
6
p < 0.0001
5
4
4
3
2
2
1
0
ClosureFAST Laser
 RECOVERY Trial7: 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%
90%
80%
70%
60%
p < 0.0001 51.3%
50%
40%
30%
20%
10%
2.2%
0%
ClosureFAST Laser
 RECOVERY Trial7: Ecchymosis
A Prospective, Multi-Center, Randomized Study

Presence of Any Ecchymosis (Post Procedure)

100%
80.5% 74.3%
80% 66.7%

60%
33.0% 35.0%
40%
18.6% 22.5%
20%
2.2%
0%
2 Days 7 Days 14 Days 30 Days

ClosureFAST Laser
 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

Sources of Reflux in
Venous Ulcer Patients8
Superficial Perforating Deep
79% 63% 50%

Incompetent perforators found in

63% of venous ulcer patients

Comprehensive care treats all

Photos courtesy of Steven A. Kaufman, MD. sources of reflux
 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
• American Heart Association, SIR, Brand et al. “The Epidemiology of Varicose Veins: The
Framingham Study”
• US Markets for Varicose Vein Treatment Devices 2006, Millennium Research Group 2005.
• Coon WW, Willis PW, Keller JB: Venous thromboembolism and other venous disease in the
Tecumseh Community Health Study Circulation 1973; 48:839-846.
• Barron HC, Ross BA. Varicose Veins: A guide to prevention and treatment. NY, NY: Facts on
File, Inc. [An Infobase Holdings Company]; 1995;vii.
• White JV, Ryjewski C. Chronic venous insufficiency. Perspect Vasc Surg Endovasc Ther
2005;17:319-27
• 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.
• Alameida JI. Lessons Learned After 2000 Endovenous Ablations. 34th Veith Symposium. Nov
14-18, 2007. New York
• Hanrahn L. et al. Distribution of valvular incompetence in patients with venous stasis
ulceration. JVS 13,6, 805-812 June 1991
• 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
• 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)