By: Alan M. Dietzek, MD, RVT, RPVI, FACS Visit VeinGlobal at http://www.veinglobal.com/ for more presentations and videos on this topic, or for more information on venous disease news, education and research.

1. Future Of RF Ablation: Continuous Or
Segmental?
Alan M Dietzek, MD, RVT, RPVI, FACSAlan M Dietzek, MD, RVT, RPVI, FACS
Clinical Associate Professor of SurgeryClinical Associate Professor of Surgery
University of Vermont College of MedicineUniversity of Vermont College of Medicine
Chief, Section of Vascular and Endovascular SurgeryChief, Section of Vascular and Endovascular Surgery
Linda and Stephen R Cohen Chair in Vascular SurgeryLinda and Stephen R Cohen Chair in Vascular Surgery
Danbury Hospital- Western CT Health NetworkDanbury Hospital- Western CT Health Network
12th
International Varicose Vein Congress:
In-Office Techniques
Lowes Hotel
Miami Beach, Fla.
April 24-26, 2014

2.  Research Grant - CovidienResearch Grant - Covidien

3. At The Start
Continuous RF Bipolar Ablation (VNUS Medical)
 VNUS Medical Technologies
Closure - 1999
ClosurePlus: integrated handle - 2003
Integrated handle
1995 -
Restore catheter

4. Next Generation VNUS RF
Continuous Bipolar RF
Closure and ClosurePlus
•Electrodes transfer RF energy (=
electromagnetic energy with freq range
300kHz – 1MHz) by direct contact with vein
wall
– EM waves vibrate atoms in vein wall
releasing thermal energy heats vein
wall to 850
C (Resistive Heating)
•Continuous catheter pullback during
treatment
•Two catheter sizes
• 6F and 8F
Bipolar Continuous Pullback Technology
0.0250.025” lumen” lumen

5. Continuous RF Bipolar Technology
Limitations
Operator Dependent
• Treatment variability 20
to inadequate energy transfer:
• Withdraw catheter too quickly (>2-3cm/min)
• speed - energy delivery
• Too little tumescence -
• Poor vein wall compression -
• Poor electrode contact with wall
• Poor result with large (>12mm) veins
•
• Small Treatment Area
• Only small area of vein is treated at any given time
2–3cm/min
Rx area

6. Slow pullback speeds
2-3cm/min
Impedance monitoring
Multiple re-treatments often necessary
GeneratorGenerator
Shut-offShut-off
CleanClean
electrodeselectrodes
HighHigh
ImpedanceImpedance
CharChar
buildupbuildup
Start AgainStart Again
Continuous RF Bipolar Technology
Limitations – cont’d

7. RF Quantum Leap
Segmental Ablation Technology- ClosureFAST
 RF Energy heats Catheter tip
(7cm heating element) to 120°
C
 Conductive Heat Transfer
(electromagnetic radiation) from
heating element to vein wall
achieves temperatures of 100-
110°C
 Vein wall heating only when
catheter is stationary
 Direct contact with vein wall not
necessary

8. Segmental Ablation Tecnology- CLF
Advantages vs Bipolar
Not operator dependent
No impedance monitoring
- No generator shut-offs
One size catheter fits all vein
diameters but not all lengths
Large treatment area:
- 6.5cm segment of vein in 20s
45cm vein treatment ~ 2 - 5min45cm vein treatment ~ 2 - 5min
(no re-treatments)(no re-treatments)
0.5cm overlap0.5cm overlap
7cm heating element7cm heating element

9. Segmental Ablation
Current Flaws
 Stiff catheterStiff catheter
 Minimum treatment length – 5cmMinimum treatment length – 5cm
 Cannot treat perforatorsCannot treat perforators
 CostCost
7cm
3cm

10. What’s Next in RF?
Back to the future
Olympus Celon RFiTT ProcedureOlympus Celon RFiTT Procedure
Developed in 2007 as alternativeDeveloped in 2007 as alternative
to VNUS bipolar RFto VNUS bipolar RF
Uses Bipolar technologyUses Bipolar technology
 Resistive heatingResistive heating of the vein wallof the vein wall
 20 J/cm vs 60-80 J/cm with CLF20 J/cm vs 60-80 J/cm with CLF

11. • AUTOMATIC CONSTANT CONTROL of the IMPEDANCE
• With AUTOMATIC POWER CONTROL
• And AUDIO FEEDBACK
CELON RFITT® RADIOFREQUENCY
The Bi-polar POWER CONTROL UNIT
Application time
(minutes and
seconds)
Power
(Watts)
• Power is adjustable

12.  953 patients (1172 GSV/228 SSV)953 patients (1172 GSV/228 SSV)
 462 patients completed study (569 GSV and 103 SSV)462 patients completed study (569 GSV and 103 SSV)
 Prospective; multicenter - EuropeanProspective; multicenter - European
 f/u between 180 and 360 days (mean 290f/u between 180 and 360 days (mean 290 ++ 84d)84d)
 Mean vein treatment length – 50 cmMean vein treatment length – 50 cm ++ 20cm20cm
 All patients treated with bipolar Celon lab RFITT systemAll patients treated with bipolar Celon lab RFITT system
 Mean treatment time: 89secMean treatment time: 89sec ++ 66 (1.8cm/sec)66 (1.8cm/sec)
Phlebology 2013;28: 38-46

13. ResultsResults
Occlusion rate at mean f/u 290 days - 92%;Occlusion rate at mean f/u 290 days - 92%;
partial occlusion 4%; failure 3%partial occlusion 4%; failure 3%
 Occlusion rate 98.4% withOcclusion rate 98.4% with
 lower power 18-20 Wlower power 18-20 W
 Catheter withdrawal rate >1.5s/cm (no failures >2.5s/cm)Catheter withdrawal rate >1.5s/cm (no failures >2.5s/cm)
 Experienced (>20 cases) operatorExperienced (>20 cases) operator
Pain scores (visual analog scale)Pain scores (visual analog scale)
 2/10 at day 1; 1 after 7d; 0 on all subsequent visits2/10 at day 1; 1 after 7d; 0 on all subsequent visits
Complications - Sensory disturbance 5.8%Complications - Sensory disturbance 5.8%
Tumescence not used in 27% of limbsTumescence not used in 27% of limbs

14. Pain Score at follow-up visits1
(Scale: 0 none to 10 max)
1
RECOVERY Study: Almeida J et al. J Vasc Interv Radiol 2009
Celon RFITT

15. Hamel-Desnos C., Desnos P.
Controversies and Updates in Vascular Surgery
Jan 17-19, 2013 Paris, France
 Prospective, single center study
 168 Saphenous veins
 126 GSV, 36 SSV, 6 ASV
 Average vein diameter - 8.2 mm (3.5-15)
 Mean power – 19W
 71% female (117); mean age 58
 Mean CEAP 2 (2 - 6); mean BMI 25 (17-43)

16. Hamel-Desnos C., Desnos P.
Controversies and Updates in Vascular Surgery
Jan 17-19, 2013 Paris, France
Results:Results:
•FU – 4y; Mean FU – 2.5yFU – 4y; Mean FU – 2.5y
•92% of complete occlusion92% of complete occlusion
• 7.2% of partial occlusion7.2% of partial occlusion
•Mean pull back timesMean pull back times
• Success: 6s/cmSuccess: 6s/cm
• Failures (partial or total): 4s/cmFailures (partial or total): 4s/cm
• *Paresthesias: 9s/cm*Paresthesias: 9s/cm
 ComplicationsComplications
• Paresthesias – 8%Paresthesias – 8%
Laser?
Not!

17. Fcare Systems EVRF Procedure
Monopolar Technology
EVRF radio frequency generator
CR45i unipolar catheter
• Flexible catheter
• Tortuous anatomy
• 5 Fr Sheath

18. Fcare Systems EVRF Procedure
Monopolar Technology
 One generator – 3 devicesOne generator – 3 devices
Needle 0.150mm - for Rx of
Spider veins and rosacea
Spider Veins
- Veinwave technology
Catheter for Rx of VVs 1
to 4mm and Perforators
Small VVs
- Not approved for use in US
Catheter CR45i for Rx
of saphenous vein
GSV/SSV
Not approved for use in US

19. EVRF Clinical Study
Piñón H, MD.
Presented at the XLIII Congress of Vascular Surgery
November 2011 Mexico.
 Prospective, non-randomizedProspective, non-randomized
 30 patients, 54 GSV30 patients, 54 GSV
 CEAP 3 – 6CEAP 3 – 6
 1 month f/u1 month f/u
Results:Results:
Occlusion rate – 92% complete, 6% - partialOcclusion rate – 92% complete, 6% - partial
without reflux, 2% partial with refluxwithout reflux, 2% partial with reflux
Pain – 0/10 in all patients at 7 daysPain – 0/10 in all patients at 7 days
 Procedure times? Complication rates?Procedure times? Complication rates?

20. EVRF Early and Midterm Results
Szabo A and Danciu P: Vein Therapy News Feb/March 2013
 150 limbs in 150 pts150 limbs in 150 pts
 Single center, Prospective?Single center, Prospective?
 Output power – 25W; 4 beeps/0.5cm?Output power – 25W; 4 beeps/0.5cm?
 f/u at 1d, 1wk, 1 to 2 monthsf/u at 1d, 1wk, 1 to 2 months
 129 GSV, 15 SSV and 6 GSV + SSV129 GSV, 15 SSV and 6 GSV + SSV
 High ligation in 6 limbs with SFJ > 20mmHigh ligation in 6 limbs with SFJ > 20mm
 Concomitant phlebectomy in all casesConcomitant phlebectomy in all cases
 ResultsResults
 Complete occlusion in 99% (149/150) at 1moComplete occlusion in 99% (149/150) at 1mo
 Postop pain score (VAS) - 2/10 (when?)Postop pain score (VAS) - 2/10 (when?)

21. VNUS Closure Plus – bipolar technology
Vein Occlusion Rates – single center results
 Weiss & WeissWeiss & Weiss11
::
 140 limbs / 120 patients140 limbs / 120 patients
 98% complete vein occlusion at 1 wk98% complete vein occlusion at 1 wk
 90%90% (19/21) complete vein disappearance under ultrasound at 2 years(19/21) complete vein disappearance under ultrasound at 2 years
 KistnerKistner22
 300 cases300 cases
 Vein occlusionVein occlusion 97%97% @ 1 year@ 1 year
 WhiteleyWhiteley33
 1022 limbs1022 limbs
 Vein Occlusion RatesVein Occlusion Rates LimbsLimbs PercentagePercentage
1 year1 year 216/217216/217 99%99%
2 year2 year 106/106106/106 100%100%
3 year3 year 26/2626/26 100%100%
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. Kistner RL. Endovascular obliteration of the greater saphenous vein: The Closure procedure. Jpn J Phlebol 2002;13: 325-33.
3. Whiteley MS, Holdstock J, Price B, Gallagher T, Scott M. Radiofrequency ablation of refluxing superficial and perforating veins using VNUS
Closure and TRLOP technique. Abstract presented at the XVII Annual meeting of the European Society for Vascular Surgery, Dublin, Ireland,
Sept. 6-8, 2003.

22. Segmental Ablation 3year Occlusion Rate - 92.9%
Kaplan Meier Analysis
3
0 5 10 15 20 25
100
99
98
97
96
95
94
93
92
Time (months)
OcclusionRate(%)
1 month
99.7%
n=337 6 Months
98.5%
n=317
1 Year
96.4%
n=286
2 Year
94.7%
n=286
30 35 40
3 Year
92.9%
n=255
ClosurePlus (continuous RF) 3 year Occlusion Rate - 84% 1
1. Merchant RF, et al. J Vasc Surg 2005; 42: 502-509

23. Future Of RFA: Continuous Or Segmental?
Summary
 New Continuous RF caths are smaller and moreNew Continuous RF caths are smaller and more
flexible than present Segmental cathsflexible than present Segmental caths
 Continuous RF still operator dependent, but withContinuous RF still operator dependent, but with
faster pullback times – may lead to less variablefaster pullback times – may lead to less variable
resultsresults
 Published data for alternative RF devices isPublished data for alternative RF devices is
sparse, short term and of poor qualitysparse, short term and of poor quality
 Segmental ablation is still theSegmental ablation is still the Gold StandardGold Standard forfor
endovenous ablation but new Continous RFendovenous ablation but new Continous RF
technologies show promisetechnologies show promise
 Catheter cost may dictate the futureCatheter cost may dictate the future

24. Go Knicks!
2013
Thank You
2014
Go Brooklyn

26. First Generation RFA Device
Results: How Good Was It?
Substantial Body of Clinical Evidence
 Over 60 publications
 Mechanism of action and pathophysiological
outcomes well understood
 4 randomized trials comparing RFA with vein stripping
surgery demonstrated superiority of RFA
 Multicenter registry involving 30+ centers worldwide
with 1222 limbs/1005 pts treated proven the durability
of the treatment with 5-year follow-up data
 Multiple independent reports validated the results of
major trials

27. First Generation RFA Device
All Randomized Trials: RFA vs. Stripping
1. Rautio T, Ohinmaa A, Perala J, Ohtonen P, Heikkinen T, Wiik H, Karjalainen P, Haukipuro K, Juvonen T.
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.
2. Lurie F, Creton D, Eklof B, Kabnick LS, Kistner RL, Pichot O, Schuller-Petrovic S, Sessa C. 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: 207-14.
3. Lurie F, Creton D, Eklof B, Kabnick LS, Kistner RL, Pichot O, Sessa C, Schuller-Petrovic S. Prospective
Randomised Study of Endovenous Radiofrequency Obliteration (Closure) Versus Ligation and Vein
Stripping (EVOLVeS): Two-year Follow-up. Eur J Vasc Endovasc Surg. 2005;29:67-73.
4. Stoetter L, Schaaf I, Bockelbrink A. Invaginating stripping, kryostripping or endoluminal radiofrequency
obliteration to treat GSV insufficiency: duplex ultrasound findings and clinical outcome postoperatively
and at 1-year follow up. 17th annual meeting of American Venous Forum. San Diego, Feb, 2005
5. Hinchliffe RJ, Ubhi J, Beech A, Ellison J, Braithwaite BD. A Prospective Randomised Controlled Trial of
VNUS Closure versus Surgery for the Treatment of Recurrent Long Saphenous Varicose Veins. Eur J
Vasc Endovasc Surg. 2005 Aug 30; [Epub ahead of print]
SummarySummary
RFA patients - significantly less pain and post-op morbidity,RFA patients - significantly less pain and post-op morbidity,
faster recovery and better quality of life than stripping patientsfaster recovery and better quality of life than stripping patients

28. First Generation RFA Device
VNUS Clinical Registry – Results
Multicenter (>30 centers);1006 patients and 1222 limbs treated
1. Merchant RF, et al. Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a
treatment for superficial venous insufficiency. J Vasc Surg 2005, 42(3): 502-509
1 Yr 2 Yrs 3 Yrs 4 Yrs 5 Yrs
Absence of reflux
417/473
88%
232/263
88%
117/133
88%
103/119
87%
98/117
84%

29. First Generation RFA Device
VNUS Clinical Registry - Results
1. Merchant RF, et al. Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a
treatment for superficial venous insufficiency. J Vasc Surg 2005, 42(3): 502-509
1 Yr 2 Yrs 3 Yrs 4 Yrs 5 Yrs
Absence of reflux
417/473
88%
232/263
88%
117/133
88%
103/119
87%
98/117
84%

30. First Generation RFA Device
VNUS Clinical Registry - Results
1. Merchant RF, et al. Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a
treatment for superficial venous insufficiency. J Vasc Surg 2005, 42(3): 502-509
1 Yr 2 Yrs 3 Yrs 4 Yrs 5 Yrs
Absence of reflux
417/473
88%
232/263
88%
117/133
88%
103/119
87%
98/117
84%
Vein occlusion
(≤ 3 cm patent stump)
412/473412/473
87%87%
232/263
88%
111/133
84%
101/119
85%
102/117102/117
87%87%

31. New Generation RFA Device
ClosureFAST Study
Multicenter (13 Study Centers in Europe and the US)
 326 patients; 396 limbs treated
 Percent Female = 73.3%
 Average Age = 47.2 ± 12.4 years
 Average Height = 170.0 cm ± 8.4 cm
 Average Weight = 74.2 kg ± 16.9 kg
 All veins treated were GSV from groin to knee
 Average vein diameter at 3 cm from SFJ 5.5 ± 2.1 mm (2.0 - 18.0mm )
 Average length of veins treated: 36.9 ± 10.6 cm
 Average energy delivery time: 2.2 ± 0.6 min
 Average procedure time (cath in to cath out): 15.2 ± 7.5m

32. CLF Occlusion Rate at 3 Years - 92.9%
Kaplan Meier Analysis
•0 •5 •10 •15 •20 •25
•100
•99
•98
•97
•96
•95
•94
•93
•92
Time (months)
OcclusionRate(%)
1 month
99.7%
n=337 6 Months
98.5%
n=317
1 Year
96.4%
n=286
2 Year
94.7%
n=286
•30 •35 •40
3 Year
92.9%
n=255
ClosurePlus 3 year Occlusion Rate - 84% 1
1. Merchant RF, et al. J Vasc Surg 2005; 42: 502-509

33. CLF Reflux Free Rate at 3 Years– 96.0%
Kaplan Meier Analysis
•0 •5 •10 •15 •20 •25
•100.0
•99.5
•99.0
•98.5
•98.0
•97.5
•97.0
•96.5
•96.0
Time (months)
RefluxFreeRate(%)
1 month
99.7%
n=337
6 Months
99.4%
n=320
1 Year
99.1%
n=292
2 Year
97.5%
n=292
•30 •35 •40
3 Year
96.0%
n=258
ClosurePlus 3 year Reflux Free Rate – 88%1
1. Merchant RF, et al. J Vasc Surg 2005; 42: 502-509

34. CEAP Clinical Class DistributionCEAP Clinical Class Distribution
Pre-treatmentPre-treatment

35. CEAP Clinical Class DistributionCEAP Clinical Class Distribution
At 36 MonthsAt 36 Months

36. Complications
Follow-up Time PointFollow-up Time Point All TimeAll Time 2 Year2 Year 3 Year3 Year
Post TreatmentPost Treatment n = 396n = 396 n = 267n = 267
EcchymosisEcchymosis 21 (5.3%)21 (5.3%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)
ErythemaErythema 9 (2.3%)9 (2.3%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)
HematomaHematoma 4 (1.0%)4 (1.0%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)
ParesthesiaParesthesia 16 (4.0%)16 (4.0%) 1 (0.3%)1 (0.3%) 1 (0.3%)1 (0.3%)
PhlebitisPhlebitis 6 (1.5%)6 (1.5%) 0 (0.0%)0 (0.0%) 1 (0.3%)1 (0.3%) 1
Skin PigmentationSkin Pigmentation 12 (3.0%)12 (3.0%) 1 (0.3%)1 (0.3%) 0 (0.0%)0 (0.0%)
Thermal Skin InjuryThermal Skin Injury 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)
Thrombus Extension / DVTThrombus Extension / DVT2
6 (1.5%)6 (1.5%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)

37. Complications
Follow-up Time PointFollow-up Time Point All TimeAll Time 2 Year2 Year 3 Year3 Year
Post TreatmentPost Treatment n = 396n = 396 n = 267n = 267
EcchymosisEcchymosis 21 (5.3%)21 (5.3%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)
ErythemaErythema 9 (2.3%)9 (2.3%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)
HematomaHematoma 4 (1.0%)4 (1.0%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)
ParesthesiaParesthesia 16 (4.0%)16 (4.0%) 1 (0.3%)1 (0.3%) 1 (0.3%)1 (0.3%)
PhlebitisPhlebitis1
6 (1.5%)6 (1.5%) 0 (0.0%)0 (0.0%) 1 (0.3%)1 (0.3%)
Skin PigmentationSkin Pigmentation 12 (3.0%)12 (3.0%) 1 (0.3%)1 (0.3%) 0 (0.0%)0 (0.0%)
Thermal Skin InjuryThermal Skin Injury 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)
Thrombus Extension / DVTThrombus Extension / DVT2
6 (1.5%)6 (1.5%) 0 (0.0%)0 (0.0%) 0 (0.0%)0 (0.0%)
1. Patient had foam sclerotherapy and phlebectomy between years 2 and 3
2. Before recommendation to place catheter ≥ 2 cm from the SFJ

38. Evolution of RF Endovenous Ablation
Summary
 ClosureFASTClosureFAST
More efficient design and reliable mode ofMore efficient design and reliable mode of
action than older RF devicesaction than older RF devices
More User FriendlyMore User Friendly
Better Vein Occlusion and Reflux Free ratesBetter Vein Occlusion and Reflux Free rates
Similar mild recovery and long term symptomSimilar mild recovery and long term symptom
relief profilerelief profile
Equivalent or lower complication ratesEquivalent or lower complication rates

39. Evolution of Endovenous Ablation:
Closure and ClosurePlus (CLP) – 1st
Generation
Design and Mode of Action
• Electrodes for transfer of RF
energy to vein wall (bipolar
technology)
– Heats vein wall to 850
C
• Continuous catheter pullback
during treatment
• Thermocouple monitors vein wall
temperature and impedance with
feedback loop to generator
• Saline drip required
• Two catheter sizes
• 6F and 8F
Bipolar Continuous Pullback Technology

40. RF Ablation
How the Device has Evolved
VNUS MedicalTechnologies is
founded - 1995
RF energy: Restore catheter
0.0250.025” lumen” lumen
Closure Catheter - 2001
ClosurePlus – 2003
Integrated handle

41. First Generation RF Device
Limitations
Operator Dependent treatment variability
Inadequate Transfer of Energy
• Pullback too fast (>2-3cm/min)
• speed – decrease energy delivery
• Inadequate tumescent compression
•Poor Electrode Contact with vein wall
• Especially vein diameters >12mm (supine)
• Only small area of vein is treated at any given
time
2–3cm/min

42. First Generation Device - CLP
Ease of Use
Slow pullback speeds
2-3cm/min
Impedance monitoring
Generator
Shut-off
Clean
electrodes
High
Impedance
Char
buildup
Start Again!!!

43. First Generation RFA Devices –
Closure and ClosurePlus
Design and Mode of Action
Electrodes for transfer of RF energy
to vein wall (bipolar technology)
– Heats vein wall to 850
C
Continuous catheter pullback during
treatment
Thermocouple monitors vein wall
temperature and impedance with
feedback loop to generator
Saline drip required
Two catheter sizes
6F and 8F

44. New Generation RF -
ClosureFAST
Design and Mode of Action
 RF Energy heats Catheter tip (7cm
heating element) to 120° C
 Conductive Heat Transfer from
heating element to vein wall achieves
temperatures of 100-110°C
 Vein wall heating only when catheter is
stationary (energy dosage not physician-
dependant)
 No impedance monitoring
 No saline drip

45. Small saphenous
Intersaphenous
Anterior
accessory
saphenous
Posterior
accessory
saphenous
Source: Laredo, J, et al. Endovenous Thermal Ablation of the Anterior Accessory Great Saphenous Vein
18%
10%
Great
saphenous
70%
Various Sources of Superficial Venous Reflux

46. What’s Next in RF?
Back to the future
Olympus Celon RFiTT ProceduOlympus Celon RFiTT Procedurere
Developed in 2007 as alternative to VNUSDeveloped in 2007 as alternative to VNUS
Uses Bipolar technologyUses Bipolar technology
 Resistive heating of the vein wallResistive heating of the vein wall
 20 J/cm vs 60-80 J/cm with CLF20 J/cm vs 60-80 J/cm with CLF

47. Celon RFiTT Catheter
Bipolar Technology - Resistive Heating

48. RF Ablation
In the Beginning
VNUS MedicalTechnologies is
founded - 1995
RF energy: Restore catheter
0.0250.025” lumen” lumen
Closure Catheter - 2001
ClosurePlus – 2003
Integrated handle

49. RF Data – Baseline for ComparisonRF Data – Baseline for Comparison
Recovery StudyRecovery Study
Almeida J et al. J Vasc Interv Radiol 2009Almeida J et al. J Vasc Interv Radiol 2009
- Multicenter, single-blinded, randomized studyMulticenter, single-blinded, randomized study
- 69 patients; 87 limbs (46 CLF; 41 EVLA – 980nm)69 patients; 87 limbs (46 CLF; 41 EVLA – 980nm)
- Patient followup at 2,7,14 & 30d post EVLAPatient followup at 2,7,14 & 30d post EVLA
- Primary endpointsPrimary endpoints
- Post-op painPost-op pain
- Severity of bruisingSeverity of bruising
- Adverse eventsAdverse events
- Secondary endpointsSecondary endpoints
Occlusion status, VCSS, Reflux, Tenderness, QOLOcclusion status, VCSS, Reflux, Tenderness, QOL
(CIVIQ2)(CIVIQ2)

50. Pain Score at follow-up visits1
(Scale: 0 none to 10 max)
0
0.5
1
1.5
2
2 Days 7 Days 14 Days 30 Days
ClosureFAST™ catheter 980 nm Laser
p < 0.0001 p < 0.0001 p < 0.0001 NS
CLF catheter
1. RECOVERY Study: Almeida J et al. J Vasc Interv Radiol 2009
0.7

51. Venous Clinical Severity Score (VCSS)
2
2.5
3
3.5
4
4.5
5
5.5
6
6.5
7
Screening 2 Days 7 Days 14 Days 30 Days
ClosureFAST™ catheter 980 nm Laser
NS
p = 0.0009
p = 0.0002
p = 0.0035
NS
Note: Lower score reflects a better QOL
CLF catheter

52. What’s Next in RF?
Back to the future
Olympus Celon RFiTT ProcedureOlympus Celon RFiTT Procedure
Developed in 2007 as alternativeDeveloped in 2007 as alternative
to VNUSto VNUS
Uses Bipolar technologyUses Bipolar technology
 Resistive heatingResistive heating of the vein wallof the vein wall
 20 J/cm vs 60-80 J/cm with CLF20 J/cm vs 60-80 J/cm with CLF
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53. Continuous Bipolar RF Technology
Limitations
2–3cm/min
Rx area

54. • Based on the same
technology as the
ClosureFast™ catheter with
a 4cm shorter heating
element
• Shorter segmental ablation
with the versatility to treat
various sources of
superficial venous reflux
7cm
3cm
ClosureFAST 3cm
Segmental RF Ablation
Most Recent Improvement
Rx 3 - 5cm vein
segments

55. Continuous Monopolar RF
 AdvantagesAdvantages
Catheters are thin (5Fr sheath) and pliableCatheters are thin (5Fr sheath) and pliable
Better for tortuous veins?Better for tortuous veins?
Significantly cheaper catheters thanSignificantly cheaper catheters than
Segmental cathetersSegmental catheters
 DisadvantagesDisadvantages
May take longer than Segmental RFMay take longer than Segmental RF
Pull back technology – may lead toPull back technology – may lead to
inconsistent resultsinconsistent results

56. Pain Score at follow-up visits1
(Scale: 0 none to 10 max)
0
0.5
1
1.5
2
2 Days 7 Days 14 Days 30 Days
ClosureFAST™ catheter 980 nm Laser
p < 0.0001 p < 0.0001 p < 0.0001 NS
CLF catheter
1
RECOVERY Study: Almeida J et al. J Vasc Interv Radiol 2009
0.7
0.2