Efficacy

Proven efficacy: Varithena® improves symptoms, appearance, and underlying GSV system incompetence1,2

SYMPTOMS RESULTS | APPEARANCE RESULTS | PHYSIOLOGICAL RESPONSE


Study designs: VANISH-1 and VANISH-2

Randomized, blinded, parallel-group, multicenter Phase 3 studies for Varithena®


Inclusion criteria

  • Saphenofemoral junction (SFJ) incompetence as evidenced by reflux of the great saphenous vein (GSV) or other major accessory vein
  • Symptomatic
  • Visible varicosities
  • CEAP clinical class 2-6
  • Age 18-75
No exclusions based on vein diameter, vein anatomy, or previous treatment


Treatment

  • VANISH-1: Single treatment session
  • VANISH-2: Optional second blinded treatment 1 week after the first
  • Maximum volume of microfoam per treatment session: 15 mL
  • Post-procedure compression therapy for 14 days


Baseline Characteristics


*VVSymQ® instrument: Patient-reported outcomes tool for varicose vein symptoms
†IPR-V3: Independent photography review of visible varicose veins (physician assessment)


Study Populations

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*Varithena® 0.125% was used as a control for the duplex response analysis to blind the clinician assessing response


Endpoints

efficacy-study-endpoints-chart.jpg


Varithena® improves symptoms2

Improvement in symptoms as measured by change in VVSymQ® Score
from baseline to Week 8
1,8

Symptoms.jpg
A reduction in VVSymQ® Score indicates an improvement in symptoms.
VVSymQ® instrument: Patient-reported outcomes tool for varicose vein symptoms


Varithena® improves varicose vein appearance1,2

Improvement in appearance as measured by change in IPR-V3 rating*
from baseline to Week 8


Symptoms-B.jpg
A reduction in IPR-V3 rating indicates an improvement in appearance.
*IPR-V3: Independent photography review of visible varicose veins (physician assessment); physicians rated appearance of patients’ visible varicosities on a 5-point scale



before-after-improvement-(1).jpg



Varithena® addresses underlying venous incompetence1,2


Physiological response to treatment as measured by duplex ultrasound at Week 8

Duplex response = Elimination of SFJ reflux and/or complete occlusion of all incompetent trunk veins

Symptoms-C-(2).jpg
*Varithena® 0.125% was used as a control for the duplex response analysis to blind the clinician assessing response
 
Learn how your eligible
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INDICATIONS

Varithena®  (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena®  improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.

IMPORTANT SAFETY INFORMATION

The use of Varithena®  is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease.

Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately. Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately.

Varithena®  can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis. The most common adverse events observed were pain/discomfort in extremity, retained coagulum, injection site hematoma or pain, common femoral vein thrombus extension, superficial thrombophlebitis, and deep vein thrombosis.

Physicians administering Varithena®  must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease and be trained in the administration of Varithena® .

See Full Prescribing Information for Varithena®.

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