VenaSeal™ closure system
Building long-term evidence with high clinical standards
No discrete segment of patency > 10 cm in the treated vein segment
No discrete segment of patency > 5 cm in the treated vein segment
*VenaSeal closure system includes nine roll-in patients.
The VenaSeal Spectrum Program is the largest post-market clinical study of the VenaSeal closure system compared to the current standards of care.
Purpose: 5-year follow-up study to assess the long-term safety and efficacy of the VenaSeal closure system.
Adverse events can include allergic reaction, inflammation, phlebitis, deep vein thrombosis, and/or pulmonary embolism.
Individual results may vary. Images courtesy of Dr. Kathleen Gibson.
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.†
Dr. Kathleen Gibson shares results of the WAVES study.
closure rate of GSV, SSV, and ASV at 1 year5
vein diameter treated successfully in a single session5
± 7 minutes is the average procedure time (for 1 target vein)7
7 actual, 3 months
0 actual, 3–12 months
Need for adjunctive procedure (phlebectomy)5
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.
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.
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.
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.
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.
Morrison N, Gibson K, Vasquez M, Weiss R, Jones A. 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.
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.
Proebstle TM. The European Multicenter Study on Cyanoacrylate Embolization of Refluxing Great Saphenous Veins without Tumescent Anesthesia and without Compression Therapy. Results presented at Charing Cross 2016; London, UK.
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.
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.
Attaran R, Bhalla A, Mena-Hurtado CI, 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.
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.