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Alert Indications, Safety, and Warnings

NONTHERMAL ABLATION Cyanoacrylate Closure

The VenaSeal™ closure system delivers immediate and lasting vein closure with its proprietary medical adhesive formula.1-5

  • Simple, segmental procedure with no risk of thermal nerve injury
  • No tumescent anesthesia — limited needle sticks 
  • Less pain and bruising than thermal energy treatment4
  • No post-procedure compression stockings required*3,4 

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VenaSeal™

Closure System

94.6% closure rate at 5 years1

9 of 10 patients would choose the VenaSeal procedure again1

75% improvement in VCSS scores from baseline1

THERMAL ABLATION Radiofrequency Energy Closure

The ClosureFast™ RFA system delivers uniform heat and gap-free ablation for lasting vein closure.6-8

  • Patented segmental procedure
  • Tumescent anesthesia
  • Less pain and bruising than laser energy treatment9
  • Post-procedure compression stockings required6

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ClosureFast™

Radiofrequency

Ablation System

91.9% closure rate at 5 years6

94.9% reflux-free rate at 5 years6

72% improvement in VCSS scores from baseline1

*

Some patients may benefit from the use of compression stockings post-procedure.

References

1

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

2

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.

3

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

4

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.

5

Morrison N, Kolluri R, Vasquez M, Madsen M, Jones A, Gibson K. Comparison of cyanoacrylate closure and radiofrequency ablation for the treatment of incompetent great saphenous veins: 36-Month outcomes of the VeClose randomized controlled trial. Phlebology. November 7, 2018;268355518810259.

6

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.

7

Proebstle TM, Alm BJ, Göckeritz O, et al. Five-year results from the prospective European multicentre cohort study on radiofrequency segmental thermal ablation for incompetent great saphenous veins. Br J Surg. February 2015;102(3):212-218.

8

ClosureFast and ClosureFast RFS Patents. Available at: https://www.medtronic.com/content/dam/medtronic-com/global/Corporate/meaningful-innovation/documents/CVG-Patent-Marking.pdf.pdf. Accessed July 10, 2019.

9

Almeida JI, Kaufman J, Göckeritz O, et al. Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: A multicenter, single-blinded, randomized study (RECOVERY Study). J Vasc Interv Radiol. June 2009;20(6):752-759.