COOLTOUCH CTEV ™ Endovenous Procedure Clinical Slide Set 7075-0083 Rev A

Venous Insufficiency Numbers 80 million have venous insufficiency1 50 – 55% of women2 40 – 45% of men2 50% of patients seek treatment for cosmetic reasons only American College of Phlebology Website RT Image, March 8, 2004

Common Symptoms of Vascular 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

Patient 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

CEAP 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

Contraindications for Endovenous Treatment 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

Treatment 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 laser

CoolTouch 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

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

Light Absorption in Tissue 810-940-980 1320 Nd:YAG 1 µm Melanin 1320 nm wavelength absorbed by water, NOT hemoglobin 10 µm Hemoglobin 100 µm 1 mm 10 mm 100 mm Water 1 m 10 m 100 m 0.1 0.2 0.3 0.4 0.5 1 2 3 Wavelength

1320 nm vs. Diodes Diodes (810 nm – 980 nm) 1320 nm 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

Clot Formation 1320nm vs. Diode After 60 seconds, porcine blood, in vitro: Diode 1320nm

Endovenous 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

Pull-Back Device Consistent speed Reusable Powered by laser Two pull-back speeds 0.5 mm/sec 1.0 mm/sec

Pre-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

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

Pre-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

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

Vein 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

Vein 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

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

Tumescent 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.

Tumescent 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

Sheath 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 FIBER 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

Laser Treatment Starting Parameters 6 Watts and 50 Hz ALWAYS 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

Laser Treatment 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

Laser Treatment 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

Laser Treatment Double-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

Laser 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

Immediate 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

Post-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)

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

1320 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

Porcine Greater Saphenous Vein (GSV) Courtesy of Mitchel P. Goldman, MD

Patient Histology Courtesy of Mitchel P. Goldman, MD Full thickness thermal damage affecting endothelium, smooth muscle and adventitia 1.3-1.5 mm.

CoolTouch CTEV Patient Results Before 2-week follow up Photos courtesy of Robert A. Weiss, MD

CoolTouch CTEV Patient Results Before 1-year follow up Photos courtesy of Robert A. Weiss, MD

CoolTouch CTEV Patient Results Before 6-month follow up Photos courtesy of John R. Kingsley, MD Adjuvant treatments also performed.

CoolTouch CTEV Patient Results Before 6-month follow up Photos courtesy of John R. Kingsley, MD Adjuvant treatments also performed.

CoolTouch CTEV Patient Results Before 6-week follow up Photos courtesy of Rick K. Wilson, MD Adjuvant treatments also performed.