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VenaCure EVLT vs. Sclerotherapy


 VenaCure EVLT Sclerotherapy

Primary Application

Varicose Veins (with underlying reflux)

Spider Veins

Success Rate(GSV Treatment)

93-98%1,2

9-26% (liquid)4-6 68-80% (foam)4,5,7

Complications


Pulmonary Embolism (PE)

None Reported3

Foam – Documented embolism and stroke (with PFO)8,9

Treatment Restrictions


Vein Diameter

None

<6 mm10

  1. Min, Khilnani, Zimmet. Endovenous Laser Treatment of Saphenous Vein Reflux: Long-Term Results. J Vasc Interv Radiol; 2003;14:991-996
  2. Navarro, Salat. Endolaser – a three year follow-up report: Implication on crossectomy and ligation and stripping. 16th Annual Congress American College of Phlebology, Nov 2002
  3. FDA reported events on Manufacturer & User Facility Device Experience (MAUDE) database (up to April 2007) since product inception. Up to date results available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm
  4. Hamel-Desnos C, et al. Evaluationof the efficacy of polidocanol in the form of foam compared with liquid form in sclerotherapy of the greater saphenous vein: initial results. Dermatol Surg. 2003 Dec;29(12):1170-5
  5. Yamaki T, et al. Comparative study of duplex-guided foam sclerotherapy and duplex-guided liquid sclerotherapy for the treatment of superficial venous insufficiency. Dermatol Surg. 2004 May;30(5):718-22
  6. Bishop CC, Fronek HS, et al. Real-time color duplex scanning after sclerotherapy of the greater saphenous vein. J Vasc Surg. 1991 Oct;14(4):505-8
  7. Kanter A, Thibault P. Saphenofemoral incompetence treated by ultrasound-guided sclerotherapy. Dermatol Surg. 1996 Jul;22(7):648-52
  8. Hanisch F et al. Stroke following variceal sclerotherapy. Eur J Med Res. 2004 May 28;9(5):282-4
  9. Forlee MV et al.. Stroke after varicose vein foam injection sclerotherapy. J Vasc Surg. 2006 Jan;43(1):162-4
  10. Myers et al. Outcome of ultrasound-guided sclerotherapy for varicose veins:medium-term results assessed by ultrasound surveillance. Eur J Vasc Endovasc Surg. 2007 Jan;33(1):116-21.PP/1393G Issue 1 10/07 Copyright Diomed Inc. One Dundee Park Suite 5/6 Andover, MA All rights reserved