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Building long-term evidence with prospective, randomized, multicenter studies1–4

Study design 

  • WAVES: Prospective, single-center, multi-investigator, postmarket study
  • FIH: Prospective, single-center study
  • eScope: Prospective, multicenter, postmarket study
  • VeClose: Prospective, multicenter, randomized, controlled trial

Two combined yellow diamonds with greater than ten written beneath it

No discrete segment of patency > 10 cm in the treated vein segment

Two combined yellow diamonds with greater than five written beneath it

No discrete segment of patency > 5 cm in the treated vein segment

VenaSeal™ system clinical study overview

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VeClose extension study five-year results4

Purpose: five-year follow-up study to assess the long-term safety and efficacy of the VenaSeal™ closure system

  • VenaSeal™ closure system closure rates remained strong at five-year follow-up.
  • No DVT, PE, or adhesive-related allergies were reported in the VenaSeal™ closure system cohort.

Great outcomes

  • 75% improvement in VCSS scores at five years4
  • 94.6% closure rate at five years4
  • 9 of 10 patients would choose VenaSeal™ procedure again at five years4

Adverse events can include allergic reaction, inflammation, phlebitis, deep vein thrombosis, and/or pulmonary embolism.

Before

3 months after

VenaSeal™ procedure

Individual results may vary. 
Images courtesy of Dr. Kathleen Gibson.

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WAVES study: Length of treated vein outcomes

Postmarket evaluation of the VenaSeal™ closure system

Studies researching cyanoacrylate closure with the VenaSeal™ closure system have been limited to moderate-sized great saphenous veins, and some have mandated postoperative compression stockings.

WAVES reports the results of cyanoacrylate closure for the treatment of the great saphenous vein (GSV), small saphenous veins (SSV), and/or accessory saphenous veins (ASV) up to 20 mm in diameter without the need for compression stockings.†

WAVES study 12-month results5,7

98%

closure rate of GSV, SSV, and ASV at 1 year5

20 mm

vein diameter treated successfully in a single session5

22 min

± 7 minutes is the average procedure time (for 1 target vein)7

37 predicted

7 actual, 3 months 
0 actual, 3–12 months 
Need for adjunctive procedure (phlebectomy)5

Return to work (mean time)‡

 
  • WAVES study5,7 (12-month data)
    • VenaSeal™ closure system
  • Rasmussen randomized clinical trial8 (1-year follow-up)
    • RFA
    • UCFS
    • EVLA
    • Stripping

Rasmussen randomized clinical trial note: 500-patient, randomized, controlled clinical trial comparing endovenous laser ablation, radiofrequency ablation, ultrasound-guided foam sclerotherapy, and surgical stripping for great saphenous varicose veins.

Maximize length of treated vein

  • Access the most distal point of reflux with no risk of thermal nerve injury1
  • Demonstrated moderate correlation between diseased vessel treatment length and symptom improvement§,9
  • Gain more distal access to the target vein, which may lead to shorter healing time for leg ulcers compared to radiofrequency ablation10
  • Attain decreased time to wound healing with VenaSeal™ closure system compared to radiofrequency ablation10

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