Holmium Laser Sclerolux®

Chronic venous insufficiency is a pathological condition that occurs when the wall and/or the valves of the lower limbs veins do not work effectively, slowing the blood return to the heart; it implies that the blood pressure remains high in the veins for long periods, causing the expansion of the valves. So the diseased veins appear swollen and dilated on the surface of the skin, creating a sense of swelling and heaviness for legs and ankles.
Techlamed proposes an innovative and mini-invasive treatment for this disease, which consists in shrinkage the caliber of the vein using the Holmium laser Sclerolux. This procedure doesn’t need anesthesia. The vein, of any diameter, will be closed with a small quantity of sclerosing foam, injected immediately after laser treatment, thus ensuring an excellent occlusion of the diseased saphenous vein.

Instructions for users

The kit Sclerolux® SCL04/80

1. Percutaneous access needle (18G, 7 cm)
2. 035 inch – 150 cm nitinol J-guidewire (with adapter to facilitate cannulation into the needle)
3. Y-connector for immediate post procedure sclerotherapy (18G, 5 cm)
4. 80 cm – 4 Fr catheter marked at 1 cm intervals
5. Lock for locking the laser fiber into the catheter
6. Holmium laser fiber (Sclerolux, cod. M210508S; 800 μm; length 200 cm)

•••

Access

1. Place the patient in reverse Trendelenburg
2. Locally anesthetize the intended access site
3. Cannulate the vein with the 18G access needle
4. Insert the guidewire
5. Remove the needle

6. Insert the catheter over the wire and into the vessel positioning its tip at the desired treatment site
7. Check the presence of the lock along the catheter
8. In case of difficult access, the use of an introducer is suggested (minimum 6 Fr; not included in the kit)

9. Remove the guidewire
10. Insert the laser fiber into the catheter

11. The laser fiber extends 1 cm beyond the catheter distal tip when the black marking on the fiber is inside the catheter luer adapter
12. Snap the lock in order to lock the fiber inside the catheter.
13. Place the patient in flat position
14. Confirm fiber tip placement with ultrasound

•••

Starting and setting the device

 

1. Connect the fiber to the console
2. Turn the key to switch the device on
3. Push Start on the touch screen

4. Set energy level (range: 100-500 mj/impulse).
5.Push ON to confirm the setting
6. Push OPER to activate the foot pedal.
When the red light stops flashing the device is ready to fire the laser

Note: the figure shows the Techlamed protocol energy setting

a) Pulsed modality
b) Impulses cycle: 2,5 s
c) Frequency: 7Hz
d) Number of impulses in every cycle: 17
e) Delivered energy in one cycle: 3.4 J
f) Red aiming beam intensity: 100 %

•••

Treatment

1. Push the foot pedal
2. Wait for 5 seconds while continuing to push on the pedal
3. Continue to push the pedal during each cycle. An acoustic signal is produced every 0.5 sec
4. Due to the laser-induced blood molecular break down, a “cloud” effect can be detected by ultrasound when delivering the energy
5. At the end of each cycle, the energy delivery stops automatically
6. Release the foot pedal and press it down again to start a new cycle

Whenever releasing the foot pedal, the energy delivery stops immediately.

•••

Laser treatment (Techlamed protocol with laser Sclerolux®)

1. Delivery of 2 consecutive cycles/cm using the following settings:

I. Pulsed mode
II. Impulse cycle: 2.5 s
III. Frequency: 7Hz
IV. Number of impulses/cycle: 17
V. Energy delivery/impulse: 200 mJ

2. In case of terminal valve incompetence and/or venous calibre > 1 cm, add a third cycle to the first treated cm, then proceed with 2 cycles/cm
3. Verify the lumen calibre reduction by ultrasound

•••

Sclerotherapy

1. Release the lock to remove the laser fiber
2. Advance the catheter 5 cm below the sapheno-femoral junction
3. Cut the distal part of the cathether in order to insert the Y-adapter
4. Place the patient in mild Trendelenburg
5. Insert a syringe containing saline solution in the Y-adapter
6. Flush the vein with saline solution
7. Inject 1 cc of foamed sclerosant
8. Withdraw the catheter while injecting the remaining sclerosant (Techlamed protocol: 1 cc/5 cm).

 

 

Download the brochure Acrobat .pdf format

Watch the video

 

Certifications:

CE Sclerolux® Laser

Techlamed - Cathfoam
CE Sclerolux® Kit

Techlamed - Cathfoam

Bibliografy:

[1] A. Frullini, D. Fortuna: Neue perspektiven fur die kollageneinschrumpfung bei venoser insuffizienz. Vasomed 2009;4: 153.
[2] A. Frullini, D. Fortuna: New perspectives in collagen shrinking for venous insufficiency. Abstract PP4-.2-10 Proceedings XVI world meeting UIP Monaco August 31-September 4 2009.
[3]. A. Frullini, D. Fortuna: New approaches for venous insufficiency: photo-induced collagen cross linking and holmium laser. Proceedings Sclerotherapy 2010 Bologna 26-27 Marzo 2010.
[4]. A. Frullini: Foam sclerotherapy: a review. Phlebolymphology 2003:40:125-129.
[5]. A. Cavezzi, A. Frullini, S. Ricci, L. Tessari: Treatment of varicose veins by foam sclerotherapy: two clinical series. Phlebology 2002;17:13-18.
[6]. A. Frullini, A. Cavezzi: Sclerosing foam in the treatment of varicose veins and teleangiectases: history and analysis of safety and complications. Dermatol Surg 2002; 28:11-15.

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