ELVeSELVeS™™

Endo Laser Vein System Endo Laser Vein System

Marc Richly, Medical Sales Manager - Biolitec AG

biolitec AGbiolitec AG

Marc Richly, Medical Sales Manager - Biolitec AG

biolitec AGbiolitec AG

biolitec AG – Step by Step ELVeS Procedure PDF biolitec AG – Step by Step ELVeS Procedure PDF

Ceralas D15, D25, D50Ceralas D15, D25, D50

WWavelengthavelength: :  980nm980nm

OptOptical Power:ical Power: 15Watt, 25Watt, 50Watt15Watt, 25Watt, 50Watt

Aiming Beam:Aiming Beam: 635nm, 4mW635nm, 4mW

Operating Mode:Operating Mode: Pulsed, Continuous (cw), Pulsed, Continuous (cw),

DermaModus (Fluence J/cmDermaModus (Fluence J/cm22))

Pulse On-Time:Pulse On-Time: 0.01-99.9 sec0.01-99.9 sec

Pulse Off-Time:Pulse Off-Time: 0.01-99.9 sec0.01-99.9 sec

biolitec – biolitec – MedizinischeMedizinische DiodenlaserDiodenlaser

980nm wavelength absorption in H980nm wavelength absorption in H22OO

980nm wavelength absorption in Hb/HbO980nm wavelength absorption in Hb/HbO22

H b O 2

H b H b - H b O 2 A b so r p t io n Sp ec tr a+

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ELVeSELVeS™™ – Endo Laser Vein System – Endo Laser Vein System

A unique Solution for treatment of venous incomA unique Solution for treatment of venous incompetencepetence

Greater Saphenous VeinGreater Saphenous Vein

Small Saphenous VeinSmall Saphenous Vein

Recurrencies Recurrencies

Reticular VeinsReticular Veins

BranchesBranches

Venous Ulcer, …Venous Ulcer, …

1991 - 19931991 - 1993 First experiencies on the application of laser energia First experiencies on the application of laser energia within veins (Nd:Yag - 1064 nm).within veins (Nd:Yag - 1064 nm).(Method is abandoned due to collateral effects and low success rates)(Method is abandoned due to collateral effects and low success rates)

1993 - 19951993 - 1995 First experiencies on the Endo-Vascular treatment of First experiencies on the Endo-Vascular treatment of flebostatic ulcersflebostatic ulcers with diode laser with diode laser (Magi et al.)(Magi et al.)

19971997 Increase of cientific comunications on the use of laser for Increase of cientific comunications on the use of laser for Endo-Venous treatment showing various advantages Endo-Venous treatment showing various advantages (Bone, Min & others)(Bone, Min & others)

19981998 The Laser Industry starts promoting multicentre trials and The Laser Industry starts promoting multicentre trials and deliver protocols for the application on GSV. deliver protocols for the application on GSV.

19991999 Application for Application for FDAFDA aprovals for the laser minimally- aprovals for the laser minimally-invasive procedure.invasive procedure.

Past…

20002000 Filing for FDAFiling for FDA

Dec.Dec. 20012001 FDA certifies FDA certifies the endo-vascular procedure for varicose the endo-vascular procedure for varicose veins veins (EVLT(EVLT™™))

March 2002March 2002 FDAFDA certifies certifies ELVeSELVeS™™

ELT / EVLT™ELT / EVLT™ Endo-venous procedure for the treatment of GSV (knee Endo-venous procedure for the treatment of GSV (knee access) access)

ELVeS™ELVeS™ Global approachGlobal approach for the treatment of vein diseases using for the treatment of vein diseases using laser energy and technology for micro-invasive laser energy and technology for micro-invasive proceduresprocedures

Consistency & Clinical CoherencyConsistency & Clinical Coherency

Past…

ELVeS™ELVeS™ Global approachGlobal approach for the treatment of vein diseases using for the treatment of vein diseases using laser energy and technology for micro-invasive procedureslaser energy and technology for micro-invasive procedures

- Long & short GSV- Long & short GSV

- Reticular veins, Collateral & superficial branches- Reticular veins, Collateral & superficial branches

- Vein Ulcers- Vein Ulcers

- Vascular Malformations- Vascular Malformations

- Haemorroids- Haemorroids

- Varicocelle- Varicocelle

- Trans-dermal Therapy - Trans-dermal Therapy (DermaMode with hand-piece)(DermaMode with hand-piece)

ELVeSTM

Endo Laser Vein System

LASER LASER Semiconductor TechnologySemiconductor Technology Objective applicationsObjective applications

FIBRE OPTICSFIBRE OPTICS Operative Flexibility Operative Flexibility Clinical evolutionClinical evolution

CLINICAL CLINICAL SStandardizationtandardization Efficacy & SafetyEfficacy & Safety

ELVeSTM

Endo Laser Vein System

Pre-Operative Ultrasound control Pre-Operative Ultrasound control

Mapping of the vein Mapping of the vein

Precise marking of the junction, position for Precise marking of the junction, position for percutaneous entry of the vein, branches and percutaneous entry of the vein, branches and perforator veinsperforator veins

ELVeSELVeS™™ – Treatment of GSV / SSV – Treatment of GSV / SSV

ELVeSELVeS™™ – Endo Laser Vein System – Endo Laser Vein System

ELVeS Treatement Kit 55cmELVeS Treatement Kit 55cm

600µm Bare Fiber (BFF 603 DL) with Luer-Lock 600µm Bare Fiber (BFF 603 DL) with Luer-Lock Connection Connection

Introduction Set Introduction Set

J-Tip Guide WireJ-Tip Guide Wire

5F Introducer Sheath / Dilator 55cm5F Introducer Sheath / Dilator 55cm

19G Entry Needle19G Entry Needle

ELVeSELVeS™™ – Endo Laser Vein System – Endo Laser Vein System

ELVeS ELVeS PLUSPLUS Treatement Kit 70cm / 100cm Treatement Kit 70cm / 100cm

600µm Bare Fiber (BFF 603 DL) with Luer-Lock 600µm Bare Fiber (BFF 603 DL) with Luer-Lock Connection Connection

Introduction Set Introduction Set

0.035 J-Tip/Straight Tip PTFE Guide Wire0.035 J-Tip/Straight Tip PTFE Guide Wire

5F OD ELVeS 5F OD ELVeS PLUS PLUS Catheter with US marker and Catheter with US marker and distance marker (every cm) distance marker (every cm)

19G Entry Needle with US Cut19G Entry Needle with US Cut

Percutaneous entry or via mini incision Percutaneous entry or via mini incision

Inserting the ELVeS Kit via „Seldinger Inserting the ELVeS Kit via „Seldinger Technique“ and advancing it towards the Technique“ and advancing it towards the sapheno-femoral junction.sapheno-femoral junction.

Distal end of ELVeS laser fibre is positioned Distal end of ELVeS laser fibre is positioned 1cm below the sapheno-femoral junction under 1cm below the sapheno-femoral junction under ultrasound guidance and visuell controll of the ultrasound guidance and visuell controll of the laser aiming beamlaser aiming beam

ELVeSELVeS™™ – Treat – Treatment of GSV / SSVment of GSV / SSV

ELVeSELVeS™™ – Treat – Treatment of GSV / SSVment of GSV / SSV

US control during for percutaneous entry of US control during for percutaneous entry of GSV / SSV GSV / SSV

Percutaneous entry or via mini incision Percutaneous entry or via mini incision

Inserting the ELVeS Kit via „Seldinger Inserting the ELVeS Kit via „Seldinger Technique“ and advancing it towards the Technique“ and advancing it towards the sapheno-femoral junction.sapheno-femoral junction.

Distal end of ELVeS laser fibre is positioned Distal end of ELVeS laser fibre is positioned 1cm below the sapheno-femoral junction under 1cm below the sapheno-femoral junction under ultrasound guidance and visuell controll of the ultrasound guidance and visuell controll of the laser aiming beamlaser aiming beam

ELVeSELVeS™™ – Treat – Treatment of GSV / SSVment of GSV / SSV

ELVeSELVeS™™ – Treat – Treatment of GSV / SSVment of GSV / SSV

Once in position a tumescent local Once in position a tumescent local anaesthesia (TLA) is injected under anaesthesia (TLA) is injected under ultrasound guidance along the whole vein ultrasound guidance along the whole vein which is going to be treated which is going to be treated

ELVeSELVeS™™ – Treat – Treatment of GSV / SSVment of GSV / SSV

The laser treatment is performed along The laser treatment is performed along the entire vessel length.the entire vessel length.

The laser treatment is performed in a a The laser treatment is performed in a a continuous (cw) pull back techniquecontinuous (cw) pull back technique

The irreversible thermal damage of the The irreversible thermal damage of the vein wall induced by the laser energy leads vein wall induced by the laser energy leads to a complete occlusion of the vein.to a complete occlusion of the vein.

Bi-lateral ELVeS treatments or Bi-lateral ELVeS treatments or combined GSV & SSV procedures can be combined GSV & SSV procedures can be performed during the same sessionperformed during the same session

ELVeSELVeS™™ – Treatment of – Treatment of GSV /SSVGSV /SSV

ELVeSELVeS™™ – Parameter GSV/SSV – Parameter GSV/SSV

Power

[ Watt ]

Treatment Mode

Treatment Energy

GSV

Treatment Energy

SSV

12 - 15 Continuous (cw) 100 J/cm (upper leg) –

40 J/cm (knee area) –

20 J/cm (lower leg)

50J/cm

Photo-thermolisis Principle: Transformation of Laser light into Thermal Energy due to absorption of the Laser Light (Lambert - Beer).

Directly related to power and duration by:

E [Joule] = POWER [Watt] * Time [s]

Example: 75J = 15 [W] * 5 [s]

ELVeSELVeS™™ – Parameter VSM/VSP – Parameter VSM/VSP

ELVeSELVeS™™ – Side Branches – Side Branches

ELVeSELVeS™™ – Side Branches – Side Branches

ELVeSELVeS™™ – Side Branches – Side Branches

ELVeSELVeS™™ – Side Branches – Side Branches

ELVeSELVeS™™ – Side Branches – Side Branches

ELVeSELVeS™™ – Side Branches – Side Branches

ELVeSELVeS™™ – Venous Ulcer – Venous Ulcer

ELVeSELVeS™™ – Venous Ulcer – Venous Ulcer

ELVeSELVeS™™ – Venous Ulcer – Venous Ulcer