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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.
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Venous Reflux Disease andCurrent 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 • Vein valves become damaged or diseased, resulting in vein valve failure • Reflux or backward flow in the veins occurs • Pooling of blood causes pressure in leg veins • Increased pressure may cause surface veins to become varicose Dilated Vein Normal Vein Heart Foot Valve Open Valve Closed Leaky Valve 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 Image courtesy of Robert A. Weiss, MD VN20-03-B 10/04
AdjunctiveProcedures • 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 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: VNUS Clinical Registry 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. VN20-03-B 10/04
The Closure Procedure Results Image courtesy of Robert Merchant, MD Pre-treatment One week post-treatment* *Individual results may vary VN20-03-B 10/04 Photos courtesy of Michael A. Vasquez, MD, F.A.C.S.
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 2Weiss 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. VN20-03-B 10/04