2006 CoolTouch Inc.

COOLTOUCH COOLTOUCH CTEV CTEV ™™

Endovenous ProcedureEndovenous ProcedureClinical Slide SetClinical Slide Set

7075-0083 Rev A

2006 CoolTouch Inc.

Venous Insufficiency NumbersVenous Insufficiency Numbers

80 million have venous insufficiency1

50 – 55% of women2

40 – 45% of men2

50% of patients seek treatment for cosmetic reasons only

1. American College of Phlebology Website

2. RT Image, March 8, 2004

2006 CoolTouch Inc.

Common Symptoms of Common Symptoms of Vascular InsufficiencyVascular Insufficiency

Most common in 70-80% of patients:* Aching Itching Burning sensation Heaviness Restless limbs

Left untreated, these symptoms may progress to: Skin changes Edema Skin ulcerations

* Venous Digest, July 2005. Nicos Labropoulos, MD

2006 CoolTouch Inc.

Patient SelectionPatient Selection

History of varicose veins caused by incompetent valves and documented reflux

Confirmed with duplex ultrasound CEAP Classification

C = Clinical severity

E = Etiology or cause

A = Anatomy

P = Pathophysiology

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CEAP ClassificationCEAP Classification C0 No signs of venous disease C1 Telangiectatic / reticular spider veins only C2 Simple varicose veins only C3 Ankle edema of venous origin C4 Skin pigment changes, no ulcerations C5 Healed venous ulcers C6 Open venous ulcers

2006 CoolTouch Inc.

Contraindications for Endovenous Contraindications for Endovenous TreatmentTreatment

Coagulopathy Ongoing deep vein thrombosis Arteriovenous malformation in the vein segment

being treated Non-palpable pedal pulses Peripheral artery disease indicated by ankle-

brachial index of < 0.70 Pregnancy Inability to ambulate Active localized or systemic infection or

immunocompromised

2006 CoolTouch Inc.

Treatment OptionsTreatment Options

Compression stockings Sclerotherapy Phlebectomy Vein stripping and ligation Endovenous radiofrequency Diode endovenous lasers

810 nm, 940 nm, 980 nm

1320 nm Nd:YAG endovenous laser1320 nm Nd:YAG endovenous laser

2006 CoolTouch Inc.

CoolTouch CTEVCoolTouch CTEV Nd:YAG solid state laser Mid-infrared wavelength at 1320 nm Fiber optic delivery

Single-use sterile disposable Non-sterile reusable Multiple fiber sizes

Chromophore for absorption is water not hemoglobin

FDA cleared for treatment of the GSV, SSV and tributary veins

2006 CoolTouch Inc.

Why CoolTouch 1320 nm ?Why CoolTouch 1320 nm ? 1320 nm energy is absorbed by vessel wall

NOT a hemoglobin-absorption dependent wavelength

Does not perforate vessel wall Energy is confined to vessel Less traumatic for patient

Mechanized fiber pull back provides precision Reusable laser fiber = cost effective treatment SaphFire™ fiber provides easiest access for the

even the most difficult veins

2006 CoolTouch Inc.

Light Absorption in Tissue Light Absorption in Tissue

1 µm

10 µm

100 µm

1 mm

10 mm

100 mm

1 m

10 m

100 m

0.1 0.5 1 2 30.40.30.2

Water

Wavelength

Hemoglobin

Melanin

1320 Nd:YAG810-940-980

1320 nm wavelength absorbed by water, NOT hemoglobin

2006 CoolTouch Inc.

1320 nm vs. Diodes1320 nm vs. Diodes

• 1320 nm absorbed by water and collagen in vein wall

• Gentle heating contracts vein leading to closure

• Minimal to no post-op pain and bruising

• Without blood, Diode energy penetrates through vein wall

• With blood present, high blood absorption by Diodes can cause extremely high temperatures and vein rupture

•Can cause pain, bruising and post-op complications

1320 nmDiodes

(810 nm – 980 nm)

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Clot Formation 1320nm vs. Clot Formation 1320nm vs. DiodeDiode

After 60 seconds, porcine blood, in vitro:

Diode 1320nm

2006 CoolTouch Inc.

Endovenous EquipmentEndovenous Equipment

CoolTouch CTEV Laser System 1320 nm laser 600 µm or SaphFire laser

fibers Pull-Back Device

Ancillary Supplies Needed Vascular access kit Duplex ultrasound Tumescent anesthesia for

comfort and thermal protection

2006 CoolTouch Inc.

Pull-Back DevicePull-Back Device

Consistent speed Reusable Powered by laser Two pull-back

speeds 0.5 mm/sec 1.0 mm/sec

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Pre-TreatmentPre-Treatment

Review medical history and sign consent for treatment

Blood thinner medications may or may not be held at the discretion of the physician

Patient should wear comfortable clothing and warm socks

Arrange for transportation home Obtain proper size compression hose

2006 CoolTouch Inc.

Pre-Treatment Pre-Treatment

Examine vein using duplex ultrasound with patient standing and/or lying down

Scan from the pertinent junction to access point

Measure and document Pertinent junction (SFJ, SPJ, other) Minimum and maximum vein diameter Any aneurysmal or tortuous segments Vein depths Potential access sites

2006 CoolTouch Inc.

Pre-TreatmentPre-Treatment

Complete final vein marking with patient in treatment position

Prep the skin from groin to toes Use skin prep that won’t wash off the vein

markings Drape affected leg with sterile drapes Identify access site

2006 CoolTouch Inc.

Vein Access Vein Access

Access the vein utilizing standard percutaneous (Seldinger) technique

A 5 FR, 45 cm long sheath with a side port should be used with blunt-tip style fiber (600µm)

A 4 FR, short sheath with a side port may be used with a protected-tip fiber (SaphFire)

Assemble and flush access devices as needed

2006 CoolTouch Inc.

Vein AccessVein Access

Inject vein access site with local anesthesia using 30g needle

Insert percutaneous access needle in vein under ultrasound guidance

Insert guide wire through needle into the vein and then remove needle

Make small nick in skin to allow for easier passage of the introducer sheath

2006 CoolTouch Inc.

Vein AccessVein Access

Thread the introducer sheath over the guide wire and confirm position

Remove guide wire Remove the dilator from the sheath Insert laser fiber and position 1-2 cm

below the pertinent junction

2006 CoolTouch Inc.

Removing Blood from the Vein Removing Blood from the Vein

1320 nm does not require blood to work Removing blood allows for more efficient

heating of vein tissue Position patient in 20º- 30º Trendelenburg Elevate the extremity being treated Encourage vein spasm External compression of the vein Use the sheath side-arm port to apply

suction to the vein

2006 CoolTouch Inc.

Tumescent AnesthesiaTumescent Anesthesia Used to provide a heat sink to prevent thermal

skin injury and local anesthesia along the vein pathway

Not promoted as a method of vein compression due to patent infringement issues*

Infiltrate under ultrasound guidance on top and around vein wall from the pertinent junction to the access site

Create a 10 mm space between the vein and the skin surface

Do not leave any segment unprotected* See CTEV Treatment Guidelines for patent information related to tumescent anesthesia.

2006 CoolTouch Inc.

Tumescent AnesthesiaTumescent Anesthesia A combination of local anesthetic (1% lidocaine

1:100,000) diluted with normal (Isotonic) saline to concentration of 0.1 - 0.2%

Optional addition of sodium bicarbonate to prevent stinging

Use straight local with 30g needle to numb needle entry sites for the 20g or 22g - 3 ½ needle used to administer the tumescent anesthesia

250cc or less (depending on the length of the vein) should be enough to provide thermal protection and adequate patient comfort

2006 CoolTouch Inc.

Sheath RemovalSheath Removal

Pull the sheath out of the vein until only a few mm is left at the skin access site

DO NOT BEGIN LASER TREATMENT WITH THE DO NOT BEGIN LASER TREATMENT WITH THE FIBER IN THE SHEATHFIBER IN THE SHEATH

Verify final position of the laser fiber at 1-2 cm below the junction

Place laser fiber in the Pull-back device

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Laser TreatmentLaser TreatmentStarting Parameters Starting Parameters

6 Watts and 50 Hz ALWAYS VERIFY AIMING BEAM BEFORE BEGINNING LASER TREATMENTALWAYS VERIFY AIMING BEAM BEFORE BEGINNING LASER TREATMENT

Initiate laser treatment for 2-3 seconds without fiber movement Observe laser tissue effect on ultrasound

Slowing or stopping of forward movement of flow Contraction of the vein Thickened appearance of vein wall

Adjust watts if needed

2006 CoolTouch Inc.

Laser Treatment Laser Treatment

Pull-Back Technique:Pull-Back Technique:

Start pull-back at 0.5 mm / sec for first 4-5 cm when treating the GSV or larger diameter veins

Switch pull-back to the 1.0 mm / sec speed where the vein narrows or when treating smaller veins

2006 CoolTouch Inc.

Laser Treatment Laser Treatment

Pull-Back Technique:Pull-Back Technique:

Pull-back speed may be slowed or stopped for a few seconds when treating a large, dilated segment of the vein or when the fiber moves past a large perforating or tributary vein

Observe fiber movement by ultrasound and by following the red aiming beam

Stop the pull-back device if laser treatment delivery is interrupted to avoid creating untreated segments

2006 CoolTouch Inc.

Laser TreatmentLaser Treatment

Double-pass TechniqueDouble-pass Technique May be used to confirm closure of the vein

near the junction Treat the beginning segment of the vein and

stop laser and pull-back Use the fiber to gently probe the treated

portion of the vein Resistance indicates complete closure-resume

laser treatment No resistance- re-treat that segment

2006 CoolTouch Inc.

Laser TreatmentLaser Treatment

Examine the treated vein with ultrasound at completion of the procedure for the following:

Vein appears more dense and thickened (echogenic)

Vein is less compressible Vein lumen noticeably smaller in size Vein does not demonstrate spontaneous flow

Record treatment data

2006 CoolTouch Inc.

Immediate Post-TreatmentImmediate Post-Treatment

Apply Steri-Strip® over access site Large bulky dressing to absorb tumescent Medi-Rip or similar type of wrap Compression hose 30-40 mmHg Immediate ambulation of the patient is

encouraged

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Post-Treatment InstructionsPost-Treatment Instructions

Frequent ambulation is encouraged Avoid heavy lifting / strenuous exercise

for a few days Avoid prolonged sitting or standing Compression stockings for 3 days to

several weeks Return for duplex ultrasound within 1 to

six weeks (1 week until experienced)

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Patient Follow-UpPatient Follow-Up

72 hours 1 to six weeks to evaluate for vein closure 3 to 6 months for repeat ultrasound 1 year

2006 CoolTouch Inc.

1320 nm Results1320 nm Results Single treatment Low rate of recurrent reflux (greater than 95%

success rate) No morbidity Minimal to no post-op pain and bruising Cosmetically pleasing – one access puncture site No downtime Less expensive per procedure and easier

technique than RF Fewer complications and less pain and bruising

than Diode lasers

2006 CoolTouch Inc.

Porcine Greater Porcine Greater SaphenousSaphenous Vein Vein (GSV)(GSV)

Courtesy of Mitchel P. Goldman, MD

2006 CoolTouch Inc.

Full thickness thermal damage affecting endothelium, smooth muscle and adventitia 1.3-1.5 mm.

Courtesy of Mitchel P. Goldman, MD

Patient HistologyPatient Histology

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CoolTouch CTEV Patient ResultsCoolTouch CTEV Patient Results

Photos courtesy of Robert A. Weiss, MD Before 2-week follow up

2006 CoolTouch Inc.

CoolTouch CTEV Patient ResultsCoolTouch CTEV Patient Results

Photos courtesy of Robert A. Weiss, MD Before 1-year follow up

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CoolTouch CTEV Patient ResultsCoolTouch CTEV Patient Results

Photos courtesy of John R. Kingsley, MD

Adjuvant treatments also performed.

Before 6-month follow up

2006 CoolTouch Inc.

CoolTouch CTEV Patient ResultsCoolTouch CTEV Patient Results

Photos courtesy of John R. Kingsley, MD

Adjuvant treatments also performed.

Before 6-month follow up

2006 CoolTouch Inc.

CoolTouch CTEV Patient ResultsCoolTouch CTEV Patient Results

Photos courtesy of Rick K. Wilson, MD

Adjuvant treatments also performed.

Before 6-week follow up