Efficacy

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

DATA ONCE AGAIN DEMONSTRATES THE EFFICACY AND DURABILITY OF VARITHENA® TREATMENT >

Study designs: VANISH-1 and VANISH-2

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

SYMPTOMS RESULTS | APPEARANCE RESULTS | PHYSIOLOGICAL RESPONSE


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

efficacy-study-pop-chart.jpg
*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
 

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