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Laser treatment of varicose veins shows clear patient benefits over surgery and other alternative treatments. These benefits include:

  • Up to 98% success rate with no scarring or hospitalization
  • Lower risk of complications
  • Fast recovery with strong patient satisfaction

These factors and others make VenaCure EVLT(TM) the fastest growing procedure for treatment of varicose veins and one which is expected to quickly become the predominant varicose vein treatment. But don’t take our word for it, hear what others are saying:

What Doctors Are Saying
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What Doctors Are Saying

* Data derived from Leerink Swann & Co. Consultant Survey Summary, April 2005, Survey of 30 vascular surgeons, interventional radiologists, and interventional cardiologists on current and expected treatment patterns of varicose veins
PP/1438 Issue 1 10/07 Copyright Diomed Inc. One Dundee Park Suite 5/6 Andover, MA All rights reserved

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What Market Analysts Are Saying
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What Market Analysts Are Saying

* Data derived from Millenium Research Group, May 2004, US Markets for Varicose Vein Treatment Devices
PP/1439 Issue. 1 10/07 Copyright Diomed Inc. One Dundee Park Suite 5/6 Andover, MA All rights reserved

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VenaCure EVLT(TM) vs. RF
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Endovenous Laser or
VenaCure EVLT(TM)		 Radiofrequency
(RF)
ClosurePlus™		 ClosureFAST™
Mode of Action
(Treatment Parameters)		 Laser
(14W , continuous pullback,
2-4 min treatment time)		 RF Energy18
(85°C, continuous pullback,
tissue / impedance
measurement, 18-24 min
treatment time)18,19		 Conductive Heat Transfer18
(120°C, segmental ablation,
no impedance measurement,
3-5 min treatment time)18,19
Patient Preference
(based on internet search results)1		 >6000 requests/month <170 requests/month
Disposable Cost $275-360 $725 Similar to ClosurePlus®
(Upgrade or New Generator Required)
Success Rate
(comparative studies)		 94-100%2,3,4,5 86-92%2,3,4,5

Unknown Long-Term
(>6 mos.) Results
(No independent,
n>100 data available
as of September 2007)

13 DVT Cases8 and 3 PE
Reported9 through
September 2007
Complications
Deep Vein Thrombosis
(DVT) or Saphenous
Thrombus Extension		 0.3%6,7 2.1%6,8
Pulmonary Embolism (PE) None Reported9 16 Cases9
Side Effects
Ecchymosis/ Hematoma Mild to Moderate (<35%)4,11,15 Mild to Moderate (<35%)4,10,11
Pain/Tenderness Mild to Moderate (<25%)4,11 Mild to Moderate (<25%)4,10,11
Paresthesia 0.08%5,15 11%5,10,12,13
(“Higher with treatment
at or below the calf”)17
# Procedures (2006)14 103,000 (laser) 78,000 Brand New
(launched May 2007)
Patient Satisfaction 99.8%15 98%16 Unknown
Reimbursement Denial Rate
(Medicare)20		 12%
(CPT Code 36478) 		26%
(CPT Code 36475)
  1. Google, Yahoo, MSN & Ask search volumes, nationally, averaged over 6 months (Oct 2006 to Mar 2007) for variety of RF terms (endovenous RF/radiofrequency, RF/radiofrequency vein treatment, Closure procedure, etc.) and variety of laser terms (EVLT, endovenous laser, varicose vein laser treatment, etc.). For more complete list of terms, refer to ‘Patients Prefer Laser’ document.
  2. Black CM, et al. Failure Rates of Endovenous Radiofrequency Ablation Compared Endovenous Laser Ablation J Vasc Interv Radiol 2005;16(2 Suppl 2):S52
  3. 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
  4. 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
  5. Almeida JI, Raines J Radiofrequency Ablation and Laser Ablation in the Treatment of Varicose Veins. Ann Vasc Surg 2006; 20:547-552
  6. 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
  7. No DVT reported (MAUDE, see footnote 9); 0.3% represents non-occlusive thrombus extension
  8. Some DVT reported (MAUDE); 2.1% and ClosureFAST cases represent a combination of DVT and non-occlusive thrombus extensions
  9. 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 ClosureFAST PE cases in VNUS 10-Q for quarter ending 09/30/07’
  10. 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.
  11. 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
  12. 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
  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. Millenium Research Group, US Markets for Varicose Vein Treatment Devices 2006. GSV procedures only. Laser volume reflects all lasers.
  15. Min, Khilnani, Zimmet. Endovenous Laser Treatment of Saphenous Vein Reflux: Long-Term Results. J Vasc Interv Radiol; 2003;14:991-996
  16. 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
  17. VNUS Website, Closure Procedure Safety Summary, Potential Complications & Risks, May 2007
  18. Lumsden AB, Peden EK. Endovenous Therapy for Varicose Veins. Presentation at “All That Jazz” meeting, New Orleans, LA, May 2007
  19. VNUS Closure Fast Website, How it Works, May 2007
  20. Part B News® How to bill correctly for varicose vein treatment. October 15, 2007. RF rate from e-mail communication from editor.

    PP/1393D Issue 4 2/08 Copyright Diomed Inc. One Dundee Park Suite 5/6 Andover, MA All rights reserved
PDF  100 to 1 Prefer EVLT over RF

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VenaCure EVLT(TM) vs. Surgery
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VenaCure EVLT(TM) Surgery
(Ligation & Stripping)
Treatment Location
(Primary)		 Office Hospital
Anesthesia Local General Anesthesia
Success Rate 93-98%1,2 77-82%3,4
Complications
Deep Vein Thrombosis (DVT)
or Saphenous Thrombus
Extension		 0.3%7.8 5.3%6
Pulmonary Embolism (PE) None Reported11
Side Effects
Ecchymosis/Hematoma Mild to Moderate (<35%)1,9.12 Significant (>50%)5
Pain/Tenderness Mild to Moderate (<25%)9,12 Moderate (28%)5
Paresthesia 0.08%1,10 14%5
Recovery
Return to normal activity 1-2 days 3.9 days5
Patient Satisfaction (would recommend to a friend) 99.8%1 N/A
  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. Sarin, Scurr, Smith. Assessment of stripping the long saphenous vein in the treatment of primary varicose veins. Br J Surg 1992;79:889-893
  4. Dwerryhouse, Davies, Harradine, Earnshaw. Stripping the long saphenous vein reduces the rate of reoperation for recurrent varicose veins: five-year results of a randomized trial. J Vasc Surg 1999;29:589-592
  5. 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.
  6. van Rij et al. Incidence of deep vein thrombosis after varicose vein surgery. Br J Surg. 2004 Dec;91(12):1582-5
  7. 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
  8. No DVT reported (MAUDE, see footnote 11); 0.3% represents non-occlusive thrombus extension
  9. 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
  10. Almeida JI, Raines J. Radiofrequency Ablation and Laser Ablation in the Treatment of Varicose Veins. Ann Vasc Surg 2006; 20:547-552
  11. 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
  12. 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

    PP/1393E Issue 1 10/07 Copyright Diomed Inc. One Dundee Park Suite 5/6 Andover, MA All rights reserved

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VenaCure EVLT(TM) vs. 1320nm Laser
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VenaCure EVLT(TM) (810nm) Laser (1320 nm)
Introduction 2002 2004
Clinical Publications >30 <51
Largest Study Size 1000 limbs2 24 limbs1
Longest Follow-Up 5 years2 1 year1
Independent Publications
(Author not Consultant of Company)		 >10 None1
Max. Vein Size Treated 2.9cm5 1.2cm1
Protocol Change of Power
(from that in publications)		 None Increased power 20%
(to 6 Watts)3
Coolant System Fans Liquid Ethylene Glycol4
Laser Weight 24 lbs 140 lbs
  1. Goldman, et al. Intravenous 1320-nm Laser Closure of the Great Saphenous Vein: A 6- to 12_Month Follow-up Study. Dermatol Surg 30:11:Nov 2004, 1380-5. All other publications from CoolTouch CTEV customer packet (2005) reviewed.
  2. Min, Khilnani. Endovenous laser ablation of varicose veins. J Cardiovas Surg 2005;46
  3. June 2005 CoolTouch CTEV Customer Update
  4. CoolTouch CTEV Operation Manual
  5. Min, Khilnani, Zimmet. Endovenous Laser Treatment of Saphenous Vein Reflux: Long-Term Results. J Vasc Interv Radiol; 2003;14:991-996

    PP/1393F Issue 1 10/07 Copyright Diomed Inc. One Dundee Park Suite 5/6 Andover, MA All rights reserved

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VenaCure EVLT(TM) vs. Sclerotherapy
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VenaCure EVLT(TM) Sclerotherapy
FDA Clearance 2002 Foam – Not Cleared
Liquid (Sotradecol) – 2004
Liquid (Other) – Not Cleared
Primary Application Varicose Veins
(with underlying reflux)		 Spider Veins
Reimbursement
(CPT code)		 $1893 (36478) $145 (36470)
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

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Compare VenaCure EVLT(TM) to:

VenaCure EVLT(TM) vs. RF Ablation
VenaCure EVLT(TM) vs. Surgery
VenaCure EVLT(TM) vs. 1320nm Laser
VenaCure EVLT(TM) vs. Sclerotherapy
 

“Clinical literature clearly shows VenaCure EVLT to be more effective and less traumatic than ligation & stripping.  I expect this procedure to replace the vast majority of L&S procedures for varicose vein treatment over the next few years.  It’s simple, easy to learn, and patients love the results.  You owe it to your patients to offer this option.”

- David Vanderpool, MD, Vascular Surgeon.  Laser and Vein Aesthetics, Brentwood, TN

“We have performed hundreds of endovenous ablative procedures in our vein practice using both radiofrequency (RF) and laser (VenaCure EVLT(TM)).  Our experience has shown EVLT to be a significantly more effective method for vein ablation compared to RF… we have seen an approximate ten-fold greater recanalization rate with RF as opposed to EVLT.  Simply put, EVLT is more effective, faster and less expensive to perform.  Any patient who would have to undergo a repeat procedure will wholeheartedly agree.”

Carl M. Black, MD. Director, Vascular and Interventional Radiology, The Intermountain Vein Center and Utah Valley Interventional Associates, Provo, UT
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