VenaSeal™ closure system
Clinical evidence
Building long-term evidence with high clinical standards
Quick links to study sections
Building long-term evidence with prospective, randomized, multicenter studies1-4
Study design
- WAVES: Prospective, single-center, multi‑investigator, post‑market study
- FIH: Prospective, single-center study
- eScope: Prospective, multicenter, post-market study
- VeClose: Prospective, multicenter, randomized, controlled trial
Definition of occlusion
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 system clinical study overview
*VenaSeal closure system includes nine roll-in patients.
VenaSeal Spectrum Program
Next-level evidence for venous care
The VenaSeal Spectrum Program is the largest post-market clinical study of the VenaSeal closure system compared to the current standards of care.
Length of treated vein outcomes
Maximize length of treated vein
- Access the most distal point of reflux with no risk of thermal nerve injury.1
- A moderate correlation was demonstrated between diseased vessel treatment length and symptom improvement.§9
- VenaSeal closure system allows more distal access to the target vein, which may lead to shorter healing time for leg ulcers compared to radiofrequency ablation.10
- Physicians observed a decreased time to wound healing with VenaSeal closure system compared to radiofrequency ablation.10
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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.
§
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, 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.
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
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.
7
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.
8
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.
9
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.
10
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.