Clinical Evidence VenaSeal™ Closure System

Building long-term evidence with high clinical standards

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

VenaSeal System Clinical Study Overview
Bar chart comparing clinical study results, highlighting VenaSeal's 94.6% closure rate at five years

VeClose Extension Study

VeClose Extension Study 5-year Results4

Purpose: 5-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 5-year follow-up.
  • No DVT, PE, or adhesive-related allergies were reported in the VenaSeal closure system cohort.

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

Comparison of a leg before and three months after VenaSeal procedure

94.6% closure rate at 5 years4

75% improvement in VCSS scores at 5 years4

9 of 10 patients would choose VenaSeal procedure again at 5 years4

Waves Study

Post-market evaluation of the VenaSeal closure system5,6

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.

Play Video This will play a video - Video thumbnail

Dr. Kathleen Gibson shares results of the WAVES Study.

Waves Study 12-month Results5,6

98% closure rate

of GSV, SSV, and ASV at 1 year5

20 mm vein diameter

treated successfully in a single session6

22 minutes average procedure duration

± 7 minutes
(for 1 Target Vein)6

Need for adjunctive procedures phlebectomy5

  • Predicted — 37 (74%)
  • Actual 3 months — 7 (14%)
  • Actual 3–12 months — 0 (0%)

Predicted versus actual adjunctive procedures statistically significant

Return to Work (Mean Time)

  • Rasmussen Randomized Clinical trial7
    (1-year follow-up)
    • EVLA
    • RFA
    • UGFS
    • Stripping
  • WAVES trial5,6
    (12-month data)
    • VenaSeal closure system

Chart showing mean number of days to return to work after vein treatment with VenaSeal was 0.2 days

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

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Acknowledgements

The WAVES study authors would like to acknowledge the work of Dr. Daniel Pepper, Dr. Leonard Su, Dr. Renee Minjarez, Micah Pepper, M.P.H., and Krissa Gunderson, B.P.H., and Lake Washington Vascular Surgeons for their assistance in the conduct of this study.

*

Includes 9 roll-in patients whose data were not included in this analysis.

Some patients may benefit from the use of compression stockings post-procedure.

Results are from different clinical studies and do not represent a head-to-head comparison of the affected devices; results may differ in a head-to-head comparison. Chart is for illustration purposes only.

References

1

Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. April 2015;61(4):985-994.

2

Almeida JI, Javier JJ, Mackay EG, Bautista C, Cher DJ, Proebstle TM. Thirty-sixth month follow-up of first-in-human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. J Vasc Surg Venous Lymphat Disord. September 2017;5(5):658-666.

3

Proebstle T, Alm J, Dimitri S, et al. Three-year follow-up results of the prospective European Multicenter Cohort Study on Cyanoacrylate Embolization for treatment of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord. March 2021;9(2):329-334.

4

Morrison N, Gibson K, Vasquez M, et al. Five-year extension study of patients from a randomized clinical trial (VeClose) comparing cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. November 2020;8(6):978-989.

5

Gibson K. Cyanoacrylate Closure of Incompetent Great, Small and Accessory Saphenous Veins without the use of Post-Procedure Compression: A Post-Market Evaluation of the VenaSeal System (WAVES trial): Twelve Month Data. Results presented at Charing Cross 2017; London, UK.

6

Gibson K, Ferris B. Cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of post-procedure compression: Initial outcomes of a post-market evaluation of the VenaSeal System (the WAVES Study). Vascular. April 2017;25(2):149-156.

7

 Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized Clinical Trial Comparing Endovenous Laser Ablation, Radiofrequency Ablation, Foam Sclerotherapy and Surgical Stripping for Great Saphenous Varicose Veins. Br J Surg. August 2011;98(8):1079-1087.