CLINICAL EVIDENCE VENASEAL CLOSURE SYSTEM

Building long-term evidence with high clinical standards

VeClose Extension Study

5-year results1

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.
VenaSeal Closure System VeClose Extension Study Key Findings

WAVES STUDY

Post-market evaluation of the VenaSeal closure system2,3

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 20mm in diameter without the need for compression stockings.*

WAVES STUDY 12 -MONTHS RESULTS2

Waves Study Closure Rate
Waves Study Procedure Duration
Waves Study Vein Diameter
Waves Study Phlebectomy
Waves Study Results - Return to Work

Acknowledgements

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

*

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.

1

Morrison, N. VeClose 5-Year Follow-up Extension Study Results. Presented at Charing Cross 2019; London, UK.

2

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. 

3

Gibson, K, and 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 (WAVES Study).Vascular; 2016:Epub May 20, 2016; 1708538116651014.

4

Rasmussen, LH, et al. Randomized Clinical Trial Comparing Endovenous Laser Ablation, Radiofrequency Ablation, Foam Sclerotherapy and Surgical Stripping for Great Saphenous Varicose Veins. Br J Surg. 2011; 98: 1079-1087.