Clinical evidence VenaSeal™ Closure System
Building long-term evidence with high clinical standards
Quick links to study sections
VenaSeal™ system clinical study overview
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.
Great outcomes
- 75% improvement in VCSS scores at 5 years4
- 94.6% closure rate 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.†
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 min
±7 minutes is the average procedure time (for 1 target vein)6
37 predicted
7 actual, 3 months
0 actual, 3-12 months
Need for adjunctive procedure (phlebectomy)5
Return to work (mean time)‡
- WAVES study5,6
(12-month data)- VenaSeal™ closure system
- Rasmussen randomized clinical trial7
(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.
Length of treated vein outcomes
Additional resources
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.
§
Demonstrated in C2-C4 patients.
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.
8
Attaran R, Bhalla A, Mena-Hurtado C, Ochoa Chaar CI. Correlation between great saphenous length of treatment zone and diameter with improvement in symptoms after ablation. J Vasc Surg Venous Lymphat Disord. November 2021;9(6):1443-1450.
9
O'Banion LA, Reynolds K, Kochubey M, et al. A comparison of cyanoacrylate glue and radiofrequency ablation techniques in the treatment of superficial venous reflux in CEAP 6 patients. J Vasc Surg Venous Lymphat Disord. September 2021;9(5):1215-1221.