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Important Risk Information

Radio Frequency Ablation

VenaCure EVLT(TM)

Radiofrequency (RF)

Primary Mechanism

Laser

Electricity

Success Rate
 (comparative studies)

94-100%1,2,8,4

86-92%1,2,8,11

Complications

 

 

  • Deep Vein Thrombosis (DVT) or Saphenous Thrombus Extension

0.3%4,5

2.1%4,6

  • Pulmonary Embolism (PE)

None Reported7

17 cases7

Side Effects

 

 

  • Bruising

Mild to Moderate (<35%)3,8,10

Mild to Moderate (<35%)8,9,10

  • Bruising w/swelling

Mild to Moderate (<25%)8,10

Mild to Moderate (<25%)8,9,10

  • Numbness

0.08%3,8,10

11%9,11,12,13

Post-Op Experience

  • Compression stockings prescribed
  • Walking immediately encouraged
  • Will feel a delayed tightness (or “pulling” sensation) 4-7 days after laser treatment which is normal and expected following a successful treatment
  • Compression stockings prescribed
  • Walking immediately encouraged

# Procedures (2006)14

103,000

78,000

Patient Satisfaction (would recommend to a friend)

99.8%3

98%15

     
  1. Black CM, et al Failure Rates of Endovenous Radiofrequency Ablation Compared Endovenous Laser Ablation J Vasc Interv Radiol 2005;16(2
          Suppl 2):S52  
    2.  
  2. Isaacs M, Gardner M, Comparison of Duplex Guided Sclerotherapy, Closure and EVLT in a Single Practice. 17th Annual Congress, American
          College of Phlebology. Aug 2003  
    3.  
  3. Min, Khilnani, Zimmet. Endovenous Laser Treatment of Saphenous Vein Reflux: Long-Term Results. J Vasc Interv Radiol; 2003;14:991-996  
    4.  
  4. Mozes G, Gloviczki P, et al Extension of saphenous thrombus into the femoral vein: A potential complication of new endovenous ablation tech
          niques J Vasc Surg 2005;41:130-5  
    5.  
  5. No DVT reported (MAUDE, see footnote 7); 0.3% represents non-occlusive thrombus extension  
    6.  
  6. Some DVT reported (MAUDE); 2.1% represents combination of DVT and non-occlusive thrombus extension  
    7.  
  7. FDA reported events on Manufacturer & User Facility Device Experience (MAUDE) database (up to September 2007) since product inception.
          Up to date results available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm  
    8.  
  8. Puggioni A, Kalra M, Carmo M, Mozes G, Gloviczki P Endovenous Laser Therapy and Radiofrequency Ablation of the Great Saphenous Vein:
          Analysis of Early Efficacy and Complications J Vasc Surg 2005;42:488-93  
    9.  
  9. Lurie, F, et al. Prospective randomized study of endovenous radiofrequency obliteration (Closure procedure) versus ligation and stripping in a
          selected patient population (EVOLVeS Study), J Vasc Surg 2003; 38(2):207-14. 
    10.  
  10. Zimmet SE. Pain, Bruising and Short-Term Efficacy after Endovenous Treatment of the Greater Saphenous Vein: The Effect of Operative
          Technique and Postoperative Care. 16th Annual Congress American College of Phlebology. Nov 2002  
    11.  
  11. Almeida JI, Raines J Radiofrequency Ablation and Laser Ablation in the Treatment of Varicose Veins. Ann Vasc Surg 2006; 20:547-552  
    12.  
  12. Rautio et al. Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: A randomized con
          trolled trial with comparison of the costs. J Vasc Surg 2002;35:958-65  
    13.  
  13. Merchant RF, DePalma RG, Kabnick LS. Endovascular obliteration of saphenous reflux: a multicenter study. J Vasc Surg. 2002
          Jun;35(6):1190-6  
    14.  
  14. Millenium Research Group, US Markets for Varicose Vein Treatment Devices 2006. GSV procedures only. Laser volume reflects all lasers. 
    15.  
  15. Weiss RA, et al. Controlled Radiofrequency Endovenous Occlusion Using a Unique Radiofrequency Catheter Under Duplex Guidance to Eliminate
          Saphenous Varicose Vein Reflux: A 2-Year Follow-up, Dermatologic Surgery, Jan 2002; 28:1: 38-42
         
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