Clinical Evidence

Multiple Single Center Results

Multi-Center International Registry Results

The VNUS international, multi-center registry results continue to demonstrate a highly effective, stable outcome with 5 year follow-up after Closure® procedure. Of patients reflux-free at 1 year follow-up, 92% remain reflux-free at latest follow-up out to 5 years.⁵

Randomized Trials

Randomized trials prove benefits of the Closure procedure vs. vein stripping. Three randomized trials of the Closure procedure vs. vein stripping, including the most recent multi-center comparative trail, show very similar results.^6,7,8 The Closure procedure in these trials resulted in:

• Less post-operative recuperation time
• Faster return to work and normal activity
• Less post-operative pain and limitation of physical activity
• Higher quality of life scores than vein stripping

In addition, the multi-center comparative trial showed fewer complications and adverse events in the Closure treated patients than patients receiving vein stripping.

• In every comparison of the two procedures in which statistically differences were observed, the result was always in favor of the Closure procedure
• 80.5% of Closure treated patients returned to normal activities within one day

In two year follow-up of our multicenter, randomized EVOLVeS trial, the Closure procedure demonstrated significant advantages over vein stripping in pain and quality of life scores.⁹

Sonographic Vein Disappearance

94% of Closure-treated saphenous veins were sonographically non-identifiable at 24 months follow-up (89% were invisible at 12 month follow-up).^5,10

Relief of Symptoms

Patients report rapid and pronounced relief of symptoms associated with superficial venous reflux in limbs treated with the Closure system.

Neovascularization

The rate of neovascularization, reportedly a cause of reflux recurrence in stripping and ligation procedures, was 0.5% at 24 month follow-up in limbs treated with the Closure procedure.

1 Weiss RA, Weiss MA. Controlled Radiofrequency Endovenous Occlusion Using a Unique Radiofrequency Catheter Under Duplex Guidance to Eliminate Saphenous Varicose Vein Reflux: A 2-Year Follow-Up. Dermatol Surg 2002;28:38-42.
2 Rosenblatt, M. Treatment of Venous Insufficiency Due to Greater Saphenous Vein Reflux with Endovenous Radiofrequency Ablation,
abstract presented at the Society of Interventional Radiology, March 27-April 1, 2003, Salt Lake City, UT.
3 Kistner RL. Endovascular Obliteration of the Greater Saphenous Vein: The Closure Procedure. Jpn J Phlebol 2002;13:325-33.
4 Whiteley, MS, Holstock JM, Price BA, Scott MJ, Gallagher TM. Radiofrequency Ablation of Refluxing Great Saphenous Systems, Giacomini Veins, and Incompetent Perforating Veins using VNUS Closure and TRLOP Technique. Abstract from Journal of Endovascular Therapy 2003;10:I-46.
5 Data on file—VNUS Medical Technologies, Inc.
6 Lurie F, Creton D, Eklof B, Kabnick LS, Kistner RL, Pichot O, Et Al. Prospective Randomized Study of Endovenous Radiofrequency
Obliteration (Closure) Versus Ligation and Stripping in a Selected Patient Population (EVOLVES Study). J Vasc Surg 2003;38:207-14.
7 Stoetter L. Schaaf I, Fendl R, Bockelbrink A. Randomized Study to Compare the Closure Procedure, Invagination Stripping and Cryo
Stripping For Treatment of the Greater Saphenous Vein. Abstract submitted to German Society for Phlebology for presentation Sept. 2003.
8 Rautio T, Ohinmaa A, PerŠlŠ J, Ohtonen P, Heikkinen T, Wiik H, Et Al. Endovenous Obliteration Versus Conventional Stripping Operation in the Treatment of Primary Varicose Veins: A Randomized Controlled Trial with Comparison of Costs. J Vasc Surg 2002;35:958-65.
9 Presented at European Society of Vascular Surgery, September 2003.
10 Pichot O, et al. Role Of Duplex Imaging in Endovenous Obliteration for Primary Venous Insufficiency. J Endovasc Ther 2000;7:451-9.