technological advances radiofrequency catheter · using segmental ablation technology™ for a fast...

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Using Segmental Ablation Technology for a fast and effective treatment with mild recovery for your patients Radiofrequency Catheter • Only the ClosureFAST catheter utilizes Segmental Ablation Technology > Allows for rapid and uniform heating of the vein > Eliminates the variability associated with a continuous pullback technology such as Endovenous Laser and the ClosurePlus™ catheter • Continuous Intra-operative Feedback from the RF Generator > Helps provide a consistent, safe, and effective treatment with temperature controlled energy delivery • Enhancements for a Simpler Procedure > Physician controls energy delivery with button in the sterile field > No saline drip required Catheter tip positioned 2cm distal to the saphenofemoral junction. Tumescent fluid is administered. 1. Catheter shaft markings allow fast and accurate catheter re-positioning between treatment cycles. No energy is delivered during re-positioning. 3. 7cm vein segment treated all at once during 20-second treatment cycle. Additional vein segments treated serially. 2. 7cm Treatment of 45cm vein length takes 3 to 5 minutes (seven treatment segments). 4. 1 2 3 4 6 7 5 Segmental Ablation Technology with the ClosureFAST Catheter ClosureFAST Catheter Ordering Information VN25-137-C 2/08 Working Heating Element Compatible Order# Description Length Length Guidewire CF7-7-60 7F ClosureFAST catheter 60 cm 7 cm 0.025” CF7-7-100 7F ClosureFAST catheter 100 cm 7 cm 0.025” Copyright © 2008 VNUS Medical Technologies, Inc. All Rights Reserved. Corporate Office VNUS Medical Technologies, Inc. 5799 Fontanoso Way San Jose, CA 95138 USA Tel: 408-360-7200 Fax: 408-365-8480 www.vnus.com Technological Advances ClosureFAST 120°C 3-5 min ClosurePlus 85°C 18-24 min 810nm laser 10-14 W 3-5 min 6 1320nm laser 8 W 7.5 min 7 Procedure Speed Comparison (45cm vein length) As with all VNUS products, the ClosureFAST catheter is latex-free To order, call VNUS Customer Service at 1-888-797-VEIN (8346), Option 3 VNUS ® Medical Technologies has a full line of products for the treatment of venous disease: Closure ® Procedure Packs and Procedure Supplies Sterile, pre-assembled packs and individually packaged accessories to perform the Closure Procedure Tumescent Anesthesia Pump and Infiltration Kit For the rapid infiltration of Tumescent Anesthesia prior to treatment Full Line of Ancillary Items For pre & post procedural treatment of your vein patient ClosureRFS Radiofrequency Stylet FDA cleared for the treatment of incompetent perforator veins 6 EVLT ® – Compare Alternatives; Diomed website 12/19/06 7 Proebstle, et. al., Abstract at ACP 18th Annual Congress (2004)

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Page 1: Technological Advances Radiofrequency Catheter · Using Segmental Ablation Technology™ for a fast and effective treatment with mild recovery for your patients Radiofrequency Catheter

Using Segmental Ablation Technology™ for a fast and effective treatment with mild recovery for your patients

Radiofrequency Catheter

• Only the ClosureFAST ™ catheter utilizes Segmental Ablation Technology™

> Allows for rapid and uniform heating of the vein > Eliminates the variability associated with a continuous pullback technology such as Endovenous Laser and the ClosurePlus™ catheter

• Continuous Intra-operative Feedback from the RF Generator > Helps provide a consistent, safe, and effective treatment with temperature controlled energy delivery

• Enhancements for a Simpler Procedure > Physician controls energy delivery with button in the sterile field > No saline drip required

Catheter tip positioned 2cm distal to the saphenofemoral junction. Tumescent fluid is administered.

1.

Catheter shaft markings allow fast and accurate catheter re-positioning between treatment cycles. No energy is delivered during re-positioning.

3.

7cm vein segment treated all at once during 20-second treatment cycle. Additional vein segments treated serially.

2.

7cm

Treatment of 45cm vein length takes 3 to 5 minutes (seven treatment segments).

4.

1 2 3 4 6 75

Segmental Ablation Technology with the ClosureFAST Catheter

ClosureFAST ™ Catheter Ordering Information

VN25-137-C 2/08

Working Heating Element CompatibleOrder# Description Length Length Guidewire

CF7-7-60 7F ClosureFAST catheter 60 cm 7 cm 0.025”CF7-7-100 7F ClosureFAST catheter 100 cm 7 cm 0.025”

Copyright © 2008 VNUS Medical Technologies, Inc. All Rights Reserved.

Corporate OfficeVNUS Medical Technologies, Inc.5799 Fontanoso WaySan Jose, CA 95138 USATel: 408-360-7200Fax: 408-365-8480www.vnus.com

Technological Advances

ClosureFAST ™ 120°C 3-5 min

ClosurePlus™ 85°C 18-24 min

810nm laser 10-14 W 3-5 min6

1320nm laser 8 W 7.5 min7

Procedure Speed Comparison (45cm vein length)

As with all VNUS products, the ClosureFAST catheter is latex-free

To order, call VNUS Customer Service at 1-888-797-VEIN (8346), Option 3

VNUS® Medical Technologies has a full line of products for the treatment of venous disease:

Closure® Procedure Packs and Procedure SuppliesSterile, pre-assembled packs and individually packaged accessories to perform the Closure Procedure

Tumescent Anesthesia Pump and Infiltration KitFor the rapid infiltration of Tumescent Anesthesia prior to treatment

Full Line of Ancillary ItemsFor pre & post procedural treatment of your vein patient

ClosureRFS™ Radiofrequency StyletFDA cleared for the treatment of incompetent perforator veins

6 EVLT® – Compare Alternatives; Diomed website 12/19/067 Proebstle, et. al., Abstract at ACP 18th Annual Congress (2004)

Page 2: Technological Advances Radiofrequency Catheter · Using Segmental Ablation Technology™ for a fast and effective treatment with mild recovery for your patients Radiofrequency Catheter

“A revolution in the treatment of varicose veins” – Alan Lumsden, MD Methodist Hospital, Houston, TX

Over 300,000 procedures performed with VNUS Closure® Catheters (ClosureFAST ™ and ClosurePlus™ catheters combined)

“While procedure time and short-term efficacy are comparable between ClosureFAST ™ and laser, we’re definitely seeing a superior patient recovery profile with ClosureFAST.” – Jose Almeida, MD, Miami, FL

“The ClosureFAST system is an important advancement that combines the speed of laser treatment with the favorable side effect profile of RF ablation.” – Prof. Thomas M. Proebstle, MD University of Pecs, Hungary

“The procedure is a pleasure to perform because it’s so quick... Most important, the patients are amazed and delighted with how fast and comfortable the procedure is” – Charles Dietzek, DO, Voorhees, NJ

Less Pain and Bruising than Endovenous Laser– for a better patient experience

Proven Clinical Efficacy– for confidence in treatment results

Pre-Treatment Vein Diameter14.5mm

Occluded Acutely Post-Treatment

Immediate vein occlusion following treatment with ClosureFAST catheter in caprine jugular vein model5

Less Pain with ClosureFASTafter Procedure1

7.0

6.0

5.0

4.0

3.0

2.0

1.0

Pain Tenderness0.0

Pai

n S

cale

: 0 -

10

Goat saphenous vein at 12 weeks after ablation.

Fibrotic Vessel Sealing5

ClosureFAST single treatment

Uniform heating pattern for the ClosureFAST catheter compared with less controlled heating withendovenous laser (EVL) in beef liver model (video available on request)

810nm EVL at 70J/cm

ClosureFAST 980 nm Laser

Moderate to Severe Ecchymosisafter Procedure1, 2

ClosureFAST Laser

100%

80%

60%

40%

30%

0%0%

49%

0%

20%

40%

60%

80%

100%

0 2 4 6 8 10 12 14

Vei

n O

cclu

sio

n R

ate

Month

Multicenter Prospective Study

Durable and Effective Treatment3 Progressive Vein Shrinkage3

Vei

n d

iam

eter

(m

m)

at 3

cm f

rom

SFJ

Pre-Tx 72H 3M 6M 1 Yr

8.0

7.0

6.0

5.0

4.0

3.0

2.0

1.0

0.0

96.2% 1-Year Vein Occlusion

Progressive shrinkage of the vein maybe a marker of long term durability.4

1 Almeida JI. Recovery trial interim results, 34th Veith Symposium. Nov 14-18, 2007. New York2 Moderate ecchymosis is defined as patients experiencing >25% but <50% of treated surface area ecchymosed; severe is defined as >50% of the surface area ecchymosed.3 Dietzek A, ClosureFAST is better than first generation radiofrequency ablation – a quantum leap forward, 34th Veith Symposium. Nov 14-18, 2007. New York4 Proebstle, et al. Treatment of the incompetent great saphenous vein by endovenous radiofrequency powered segmental thermal ablation: First clinical experience. J Vasc Surg 2008;47:151-6.5 Lumsden AB, Peden EK, Clinical Use of the New VNUS ClosureFAST Radiofrequency Catheter. EV Today Supplement. 2007 Jan 7-10, 2007

Compatible with VNUS RFGPlus™ generator