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

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

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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

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Venous Reflux Disease1. 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 VeinNormal VeinHeart

Foot

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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

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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

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Conservative Treatments

• Leg elevation

• Compression stockings

• Unna boot

• NOTE: Conservative treatments often fail due to poor patient compliance

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Adjunctive Procedures

• Sclerotherapy

• External lasers and

intensed pulsed light

• Used to treat small

superficial or “spider” veins

Image courtesy of Robert A. Weiss, MD

Image courtesy of Robert A. Weiss, MD

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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

Images courtesy of Kenneth Harper, MD

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The Closure® Procedure

• The VNUS Closure procedure is a minimally invasive treatment alternative to vein stripping

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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

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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 18th annual meeting of European Society for Vascular Surgery September 2004; Innsbruck, Austria.

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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 varyPhotos 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 member2

• 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; 28:38-42. 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.

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