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VIEW-VLU clinical study

The prospective, multicenter, open label 12-month phase 4 registry confirmed Varithena’s impact on venous leg ulcers.

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The VIEW-VLU study evaluated venous leg ulcer healing rate, recurrence rate, and patient reported outcomes for Varithena. 

Key study results

In a challenging population, treatment of venous leg ulcers with Varithena showed rapid initial wound healing and sustained improvements in quality of life and pain.1

  Initial closure

12-Month closure

  Symptom improvement

Patient characteristics

  • Obese to extremely obese (36 + 10.2 BMI)    
  • Chronic ulcers (7.5 months + 12 months at first encounter)
  • Severity of ulcers
    • 26.3% circumferential wound
    • 12.5% hospitalization for target ulcer
    • 27.5% of ulcers were previously treated

Study methods

  • Total injection sites 2.1 ± 1.6
  • Varithena volume injected (mL): 
    • 3.9 + 5.7 above the knee
    • 9.4+ 4.5 below the knee
  • Follow up visits at 1-week, 12 weeks, and 12 months; phone calls at 6 months post treatment and 3-months post wound closure

VIEW-VLU did not exclude patients based on wound size or wound age, leading to a challenging patient population.

See how Varithena microfoam impacts a venous leg ulcer.

Hear Principal Investigator Dr. Michael Shao discuss the unique method and distinctive results of the VIEW-VLU study.

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References

1. Shao MY, Harlin S, Chan B, Santangelo K, FukayaE, Stoughton J, KolluriR; VIEW-VLU Investigators. VIEW-VLU observational study of the effect of Varithena on wound healing in the treatment of venous leg ulcers. J VascSurg Venous LymphatDisord. 2023 Mar 25:S2213-333X(23)00131-2. doi: 10.1016/j.jvsv.2023.01.011. Epubahead of print. PMID: 36972751

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®

Varithena™ is a registered trademark of Boston Scientific. All other trademarks are property of their respective owners.
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