CLINICAL EVIDENCE VENASEAL CLOSURE SYSTEM

Building long-term evidence with high clinical standards

VECLOSE 36-MONTH RESULTS1

THE RESULTS YOU HAVE COME TO EXPECT

  • One of the largest multicenter, randomized prospective comparisons of superficial venous ablation technologies
  • No DVT, PE or adhesive-related allergies were reported in the VenaSeal closure system study arm
  • 94.4% closure rate at 3 years

 

VeClose Trial 36-Month Results

Definition of Occlusion

VeClose Occlusion >10

No discrete segment of patency >10 cm in the treated vein segment

VenaSeal Occlusion >5

No discrete segment of patency >5 cm in the treated vein segment


Study Design

  • FIH: Prospective, single-center study
  • eSCOPE: Prospective, multicenter, post‑market study
  • VeClose: Prospective, multicenter, randomized controlled trial
  • WAVES: Prospective, single-center, multi‑investigator, post‑market study

WAVES STUDY

Post-market evaluation of the VenaSeal closure system4,5

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 RESULTS4

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. VenaSeal Closure System vs. Radiofrequency Ablation for Incompetent Great Saphenous Veins (VeClose). 36-Month Results presented at: IVC; April 20,2017; Miami, FL.

2

Morrisville, N.C., Giovino, K. Sapheon™ Closure System Feasibility Study Print Date Final Clinical Study Report. Medtronic. 2014;CR-10669-03 (Rev A). 

3

Proebstle, T.M. The European Multicenter Study on Cyanoacrylate Embolization of Refluxing Great Saphenous Veins without Tumescent Anesthesia and without Compression Therapy. eSCOPE Three-year Data. Charing Cross 2016. 

4

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. 

5

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.

6

Rasmussen, L.H., 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.