ELVeS™ Endo Laser Vein System biolitec AG ELVeS™ Endo Laser Vein System Marc Richly, Medical Sales Manager - Biolitec AG

Marc Richly, Medical Sales Manager - Biolitec AG

biolitec AG – Step by Step ELVeS Procedure PDF

Ceralas D15, D25, D50 biolitec – Medizinische Diodenlaser Wavelength:  980nm Optical Power: 15Watt, 25Watt, 50Watt Aiming Beam: 635nm, 4mW Operating Mode: Pulsed, Continuous (cw), DermaModus (Fluence J/cm2) Pulse On-Time: 0.01-99.9 sec Pulse Off-Time: 0.01-99.9 sec

980nm wavelength absorption in H2O

980nm wavelength absorption in Hb/HbO2

ELVeS™ – Endo Laser Vein System A unique Solution for treatment of venous incompetence Greater Saphenous Vein Small Saphenous Vein Recurrencies Reticular Veins Branches Venous Ulcer, …

Past… 1991 - 1993 First experiencies on the application of laser energia within veins (Nd:Yag - 1064 nm). (Method is abandoned due to collateral effects and low success rates) 1993 - 1995 First experiencies on the Endo-Vascular treatment of flebostatic ulcers with diode laser (Magi et al.) 1997 Increase of cientific comunications on the use of laser for Endo-Venous treatment showing various advantages (Bone, Min & others) 1998 The Laser Industry starts promoting multicentre trials and deliver protocols for the application on GSV. 1999 Application for FDA aprovals for the laser minimally- invasive procedure.

Consistency & Clinical Coherency Past… 2000 Filing for FDA Dec. 2001 FDA certifies the endo-vascular procedure for varicose veins (EVLT™) March 2002 FDA certifies ELVeS™ ELT / EVLT™ Endo-venous procedure for the treatment of GSV (knee access) ELVeS™ Global approach for the treatment of vein diseases using laser energy and technology for micro-invasive procedures Consistency & Clinical Coherency

ELVeSTM Endo Laser Vein System ELVeS™ Global approach for the treatment of vein diseases using laser energy and technology for micro-invasive procedures - Long & short GSV - Reticular veins, Collateral & superficial branches - Vein Ulcers - Vascular Malformations - Haemorroids - Varicocelle - Trans-dermal Therapy (DermaMode with hand-piece)

ELVeSTM Endo Laser Vein System LASER Semiconductor Technology Objective applications FIBRE OPTICS Operative Flexibility Clinical evolution CLINICAL Standardization Efficacy & Safety

ELVeS™ – Treatment of GSV / SSV Pre-Operative Ultrasound control Mapping of the vein Precise marking of the junction, position for percutaneous entry of the vein, branches and perforator veins

ELVeS™ – Endo Laser Vein System ELVeS Treatement Kit 55cm 600µm Bare Fiber (BFF 603 DL) with Luer-Lock Connection Introduction Set J-Tip Guide Wire 5F Introducer Sheath / Dilator 55cm 19G Entry Needle

ELVeS™ – Endo Laser Vein System ELVeS PLUS Treatement Kit 70cm / 100cm 600µm Bare Fiber (BFF 603 DL) with Luer-Lock Connection Introduction Set 0.035 J-Tip/Straight Tip PTFE Guide Wire 5F OD ELVeS PLUS Catheter with US marker and distance marker (every cm) 19G Entry Needle with US Cut

ELVeS™ – Treatment of GSV / SSV Percutaneous entry or via mini incision Inserting the ELVeS Kit via „Seldinger Technique“ and advancing it towards the sapheno-femoral junction. Distal end of ELVeS laser fibre is positioned 1cm below the sapheno-femoral junction under ultrasound guidance and visuell controll of the laser aiming beam

ELVeS™ – Treatment of GSV / SSV US control during for percutaneous entry of GSV / SSV

ELVeS™ – Treatment of GSV / SSV Percutaneous entry or via mini incision Inserting the ELVeS Kit via „Seldinger Technique“ and advancing it towards the sapheno-femoral junction. Distal end of ELVeS laser fibre is positioned 1cm below the sapheno-femoral junction under ultrasound guidance and visuell controll of the laser aiming beam

ELVeS™ – Treatment of GSV / SSV

ELVeS™ – Treatment of GSV / SSV Once in position a tumescent local anaesthesia (TLA) is injected under ultrasound guidance along the whole vein which is going to be treated

ELVeS™ – Treatment of GSV /SSV The laser treatment is performed along the entire vessel length. The laser treatment is performed in a a continuous (cw) pull back technique The irreversible thermal damage of the vein wall induced by the laser energy leads to a complete occlusion of the vein. Bi-lateral ELVeS treatments or combined GSV & SSV procedures can be performed during the same session

ELVeS™ – Parameter GSV/SSV Power [ Watt ] Treatment Mode Treatment Energy GSV SSV 12 - 15 Continuous (cw) 100 J/cm (upper leg) – 40 J/cm (knee area) – 20 J/cm (lower leg) 50J/cm

ELVeS™ – Parameter VSM/VSP 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]

ELVeS™ – Side Branches

ELVeS™ – Side Branches

ELVeS™ – Side Branches

ELVeS™ – Side Branches

ELVeS™ – Side Branches

ELVeS™ – Side Branches

ELVeS™ – Venous Ulcer

ELVeS™ – Venous Ulcer

ELVeS™ – Venous Ulcer