Radio Frequency Ablation
|
|
VenaCure EVLT(TM) |
Radiofrequency (RF) |
|---|---|---|
|
Primary Mechanism |
Laser |
Electricity |
|
Success Rate |
94-100%1,2,8,4 |
86-92%1,2,8,11 |
|
Complications |
|
|
|
0.3%4,5 |
2.1%4,6 |
|
None Reported7 |
17 cases7 |
|
Side Effects |
|
|
|
Mild to Moderate (<35%)3,8,10 |
Mild to Moderate (<35%)8,9,10 |
|
Mild to Moderate (<25%)8,10 |
Mild to Moderate (<25%)8,9,10 |
|
0.08%3,8,10 |
11%9,11,12,13 |
|
Post-Op Experience |
|
|
|
# Procedures (2006)14 |
103,000 |
78,000 |
|
Patient Satisfaction (would recommend to a friend) |
99.8%3 |
98%15 |
- Black CM, et al Failure Rates of Endovenous Radiofrequency Ablation Compared Endovenous Laser Ablation J Vasc Interv Radiol 2005;16(2 Suppl 2):S52
- 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
- Min, Khilnani, Zimmet. Endovenous Laser Treatment of Saphenous Vein Reflux: Long-Term Results. J Vasc Interv Radiol; 2003;14:991-996
- Mozes G, Gloviczki P, et al Extension of saphenous thrombus into the femoral vein: A potential complication of new endovenous ablation techniques J Vasc Surg 2005;41:130-5
- No DVT reported (MAUDE, see footnote 7); 0.3% represents non-occlusive thrombus extension
- Some DVT reported (MAUDE); 2.1% represents combination of DVT and non-occlusive thrombus extension
- 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
- 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
- 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.
- 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
- Almeida JI, Raines J Radiofrequency Ablation and Laser Ablation in the Treatment of Varicose Veins. Ann Vasc Surg 2006; 20:547-552
- Rautio et al. Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: A randomized controlled trial with comparison of the costs. J Vasc Surg 2002;35:958-65
- Merchant RF, DePalma RG, Kabnick LS. Endovascular obliteration of saphenous reflux: a multicenter study. J Vasc Surg. 2002 Jun;35(6):1190-6
- Millenium Research Group, US Markets for Varicose Vein Treatment Devices 2006. GSV procedures only. Laser volume reflects all lasers.
- 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






