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					“Endo Laser Vein System (ELVeS™)”
                  by biolitec


  A unique and complete
  solution for treatment of
  venous incompetence
  …




               ELVeS™ by biolitec
       Topics

• Why ELVeS™ ...
• What is ELVeS™ for ...
  – How ELVeS™ works
    ...
  – Standard procedures
    ...
• What ELVeS™ is …
• Why biolitec ...

            ELVeS™ by biolitec
          Why ELVeS™ -
   advantages for the physicians

• Innovative and complete solution for the
  treatment of varicose veins
• Allows you to treat all conditions resulting
  from venous incompetence
• Versatile and easy to use system
• Treatments can be performed on an
  outpatient basis
• Cost effective solution

              ELVeS™ by biolitec
         Why ELVeS™ -
    advantages for the patients

• Gentle, moderate and yet effective
  method of treatment
• Minimal discomfort
• Short treatment time
• Excellent aesthetic results
• A rapid return to normal activities


           ELVeS™ by biolitec
What is ELVeS™ for ...



Applications             Under evaluation
• Saphenous Veins        • Recurrences
• Reticular Varices
                         • Ulcera Prevention
• Branch Varices
• Spider Veins           • Ulcera Treatment
• Telangiectasia


             ELVeS™ by biolitec
                        Optimal absorption
  100                                               hemoglobin saturated 26,7 g/L
                      freq. d. Nd:YAG               hemoglobin 26,7 g/L
                            diode                   water
                           532 nm

   10




    1
                                                         diode   Nd:YAG
                                                        980 nm   1064 nm

                       argon
   0,1
                     488/514 nm




  0,01
         300   400      500       600   700   800     900    1000   1100    1200    1300


Photobiology research has identified 980 nm as the optimal
wavelenght for absorption in H2O und Hb–HbO2. This enables to
achieve better results with lower energy settings.


                              ELVeS™ by biolitec
Preparation: Diagnosis
   for Varicose Veins


►Duplex ultrasound
 It is necessary to know exactly
 which veins have abnormal valves
 and where those veins are in the
 leg that allows to plan accurate
 treatment


                ELVeS™ by biolitec
          Standard Procedures

► Treatment of insufficient Vena Saphena Magna
      • Compression
      • Medicaments
      • Crossectomie
      • Stripping
      • TRIVEX
      • VNUS
      • Chiva
      • Kryo-method




                 ELVeS™ by biolitec
  Compression and Medicaments

► Compression bandages or stockings
      • Primary basis treatment to assist the muscle pump
      • Increase the blood flow in the veins

► Medicaments
      • Oedema protectiva to decrease permeability of the
        vein wall
      • Diuretic agents for drainage



  Both methods help for a time but do not
  solve the problem.

                 ELVeS™ by biolitec
     Crossectomie and Stripping

► Crossectomie
      • Preparation and ligation of the sapheno-femoral
        junction

► Stripping
      • Removal of the vein by extraction of the complete
        vein with a special catheter

  Stripping destroys the connective tissue and
  leaves scars. Recovery time is around 2-3
  weeks. Round about 40 % of the patients
  have recurrences.


                ELVeS™ by biolitec
                                        Stripping vs. ELVeS
                                     Treat.                     Patient          Patient        Recur.
                                     Time                      Hospital.        Recovery        Ratio

                                                                                1 (one) day   Less than
   ELVeS                            30 – 45                                                     10%
                                                                  2 Hours       to resume
    (GSF/SSF)                        min.                                                     (three years follow
                                                                                 activities           up)




   Vein
                                    30 – 60                                                   More than
 Strippin                                                     2 to 5 days       7 – 14 days
                                     min.                                                       20%
     g
* Calculated over two years , on Ceralas 15 and 50 treatments per year

^ Patient can resume normal activities if they are not involved with running,
weight lifting or similar




                                                  ELVeS™ by biolitec
       TRIVEX and VNUS
► TRIVEX
   •   In this procedure, the surgeon views the vein using
       a transilluminating light and removes it with a
       small rotating knife

  Needs a great number of incisions and may
  cause damages to surrounding tissues


► VNUS closure
         • Closure with a catheter that delivers
           radiofrequency (RF) energy to the vein wall,
           causing it to heat, collapse, and seal shut

  Catheter only usable for big veins. Catheter
  is very expensive (1400 €)


                             ELVeS™ by biolitec
    CHIVA and Kryo-method

► CHIVA
      • The blod flow is stopped by clips at special
        analysed points

  Frequently appearance of recurrences


► Kryo-method
      • Stripping with a special frozen catheter


  Destroys the connective tissue and leaves
  scars. Recovery time is around 2-3 weeks


                   ELVeS™ by biolitec
    Standard Procedures

►Treatment of insufficient branch
 varices and reticular veins
    • Compression
    • Medicaments
    • Micro-surgery
    • Sclerotherapy



           ELVeS™ by biolitec
         Micro-surgery

► Extraction of the branch varices by
  fishing them with a hook or a wire
  through a small incision


   Destroys the connective tissue and
   need some days for healing
   Can not be performed with patients
   taking anti-coagulants or with
   impaired circulation, because they
   have to wear stockings after the
   procedure


                 ELVeS™ by biolitec
               Sclerotherapy

► Injections of a special solution into the problem
  vein make the vein close up, collapse and
  eventually disappear from sight

  Can cause allergic reactions, discoloration
  or decoloration.
  Reports about varying rates of recanalization,
  10-42% in 1 year, depending on operator,
  technique and sclerosant used

                  ELVeS™ by biolitec
ELVeS – Method for the
Great Saphena Vein 1
• Map the course of the vein
• Anaesthetised by local intradermal
  injection
• Entry into the vein is undertaken using
  ultrasound guidance
• The guide wire is then introduced into the
  needle and advanced into the vein
• The entry needle is withdrawn and the
  introducer sheath and dilator are inserted
  over the guide wire and into the vein
• The guide wire is then removed and the
  laser fibre is inserted into the introducer
  sheath and advanced along its length
• The fibre is advanced to a position 2
  centimeters below the sapheno-femoral
  junction to preserve the integrity of the
  femoral vein from the first pulse of laser
  energy


                      ELVeS™ by biolitec
ELVeS – Method for the
Great Saphena Vein 2


• A tumescent local anaesthesia is
  performed. This type of anaesthesia
  creates a cushion of water around
  the vein to protect the perivenous
  tissue
• The laser fibre is withdrawn by
  around 3 millimeters between each
  pulse of laser energy
• Immediately after the treatment,
  ultrasound control confirms the
  retraction and occlusion of the vein




                  ELVeS™ by biolitec
 ELVeS – GSV Parameter
    Saphena           Power        Pulse lenght   Pulse interval
     [ mm ]           [ Watt ]      [ seconds ]    [ seconds ]



      Sup 8           10 - 12         1.5 – 2           1
 Sup/Equal 6 - 8        8-9           1.5 - 2           1

  Between 4 -6          7-8           1 – 1.5           1


Lasering time 3 - 5 minutes
Complete Treatment time: round about 45 minutes



                     ELVeS™ by biolitec
ELVeS – Advantages GSV-treatment

• Outpatient procedure
• Quick and easy to perform
• Minimally invasive and less traumatic
• No scarring
• Local anaesthesia sufficient
• Excellent clinical and aesthetic results
• Closure of vein can be controlled
  parallel to lasering
• Reduced procedure costs


            ELVeS™ by biolitec
 Endo venous laser treatment –
          GSV-data

• First treatments in 1998
• Until now more than 500 treatments
  are      published    (Min,  Navarro,
  Proebstle, Gerard …)
• Up to 2 year follow ups (published)
  reported of an efficacy between 95-98
  % complete closure

           ELVeS™ by biolitec
   Necessary Accessories for GSV
              treatment
► ELVeS diode laser
► Duplex Ultrasound
► Hollow needle 16 G
► ELVeS Saphena Treatment Kit

       • 0.0035” J-tip guide wire
       • 5 Fr Introducer sheath
       • ELVeS 600 µm fibre




                  ELVeS™ by biolitec
ELVeS - Treatment of Branch Varices and Reticular
Veins


• Mark the run of the vein by
  small circles
• Local anaesthetisia with a
  Chlorethyl cooling spray
• Injection with a small needle
• Lasering 3 x with 6 W, pulse
  length of 0.5 -1 s and break of
  1s
• Every 1 – 2 cm of the vein set
  3 laser pulses
• The vein disappeared directly
• Treatment duration 5 – 10 min

                    ELVeS™ by biolitec
Before – After Pictures




             ELVeS™ by biolitec
   ELVeS - Advantages for Endovenous
   Treatment of Branch Varices and
   Reticular Veins

• No decoloration of skin, as sometimes happened during
  lasering in non-contact method
• No discoloration (discoloration sometimes appears after
  sklerotherapy)
• You can use this method also by patients that gets
  anticoagulation drugs
• You can treat patient with arterial disturbances of perfusion,
  because no compression is needed
• No skin burning
• Free of pain
• Patients are satisfied
• Can be performed in every practice
• A good method also for all dermatologists

                     ELVeS™ by biolitec
 Necessary Accessories for Treatment
  of Branch Varices and Reticular Veins


► ELVeS diode laser
► ELVeS hollow needle (min. 25 G)
► 220 or 400 µm fibre




             ELVeS™ by biolitec
     Spider veins and Telangiectasia

►Spider veins and telangiectasia are
  superficial veins that shine through the skin

    Spider veins and telangiectasia are a
    cosmetic problem and sometimes signal
    that there could be insufficient veins




                ELVeS™ by biolitec
    Standard Procedures

►Treatment of Spider Veins
    • Sclerotherapy
    • Laser therapy




            ELVeS™ by biolitec
    ELVeS – Transcutaneous Treatment of
                Spider Veins

► Non-contact method with a focussing hand-piece; the energy is
  defocused at the surface tissue to avoid skin burning
► Vessels up to 1.5 mm in diameter can be
  successfully treated by this technique




                     ELVeS™ by biolitec
       There are a large number of
      variables associated with the
                treatment

•   Blood vessel size
•   Blood vessel colour
•   Blood vessel depth in the skin
•   Absorption of the laser light
•   Skin type/colour
•   Laser spot size
•   Pulse duration/Fluence
•   Laser wavelength

               ELVeS™ by biolitec
            Treatment
The pulses are partially overlapping. This
   leads to a complete closure of the vein,
   but due to the heat accumulation the
   damage of the surrounding tissue and
   the pain fort he patient will be
   tremendous.

The pulses are placed in to big distances.
   The vein will not be closed completely
   and may be recanalised.


Optimal closed veins. The pulses
  are close together but they do
  not overlap.


                          ELVeS™ by biolitec
 Necessary Accessories for Treatment
   of Spider Veins and Telangiectasia


► ELVeS diode laser
► Focussing hand-piece with 0.6; 1.0; 1.5 or 2.5
  mm spot size




              ELVeS™ by biolitec
  ELVeS – Percutaneous Treatment of
                Ulcera
              (Studies America)


►Laser light is well known to have
  beneficial effects on healing wounds

     • Encourages the wound healing process
     • Reducing significantly the healing time
     • Free of side effects



                ELVeS™ by biolitec
ELVeS – Percutaneous Treatment of Ulcera
               (Studies America)

► Treatment of the wound with 5 watts in criss-cross-
  pattern leads to

   • Reduction of area of ulcer
   • Reduction of number of microbial colonies

   • Effect in diabetic patients was stronger




                     ELVeS™ by biolitec
              Further Application fields
► Recurrences, also for bigger ones
► Lasering the remaining veins after an operation to separate the
  venous valve at the groin
► Prevention of ulcera by lasering the veins shortly before an open
  wound appears
► Closing the insufficient vein that leads to the open wound




                        ELVeS™ by biolitec
ELVeS – Complete Solution for treatment
        of venous incompetence

                     Saphena
                      magna
        Reticular                 Telangi-
         Varices                  ectasia
   Branch                               Ulcera
   Varices                            Prävention


       Spider
                                  Recurrences
       Veins           Ulcera
                     Treatment


             ELVeS™ by biolitec
Why targeting Varicose Veins – European
 Market

  • Varicose veins are a frequent and occurring condition affecting up
    to 40% of women and 20% of men (Caucasian)

  • Around 1 (one) Million of Stripping procedures are performed each
    year between the US and Europe

  • In France and Italy around 200,000 procedures are performed

  • 300,000 procedures are performed in Germany

  • Millions of Euros in productivity are lost each year in the EC for
    stripping procedures’ “recovery” time



                       ELVeS™ by biolitec
Why should a patient choose
 ELVeS?

► Minimal invasive treatment
► Short treatment time
► Local anaesthesia is sufficient
► No side effects
► Excellent medical and aesthetic results
► A rapid return to normal activities
► No allergic reaction

                    ELVeS™ by biolitec
Market Segments – Two special target
              groups




30 – 60 years looking for a        60+ who are not clinically
more “friendly” and “lunch-        suitable for Surgical (general
break” solution to their           anaesthetics!) procedures
varicose vein problem



                  ELVeS™ by biolitec
                     Why ELVeS™
     Features                  Benefit      Emotional Rewards


 Laser Light           Quick Patient      Offering a “state-
(980nm)                 Recovery Time       of-the-Art” solution
                                            to patients
                        ALL vein can be    Responsive offer
Flexibility of         treated             to ALL their V.V.
available Delivery                          related problems
Systems                 Financial Risk     Great investment
                        reduced             reassurance
After Sales Support
(Clinical / Service)



                       ELVeS™ by biolitec
                     Why Biolitec
 Profitable core business of medical lasers and probes for a
  new micro/mini invasive approach

   • Surgery – Dermatology – Dental – Ophthalmology

 The only Photodynamic therapy (PDT) supplier worldwide
  for all three core competencies:

   • Photosensitizers - Lasers – Delivery systems


 Development of technology to a level of scientific
  excellence, quality of service and integrity for both
  ourselves and society


                     ELVeS™ by biolitec
biolitec group :                      History                                                              b io lit e c   A G




                                                                                          ELVeS and Foscan
                                                                                          ELVeS and Foscan

                   -first FDA-approved diode laser (980nm)
                   -first FDA-approved diode laser (980nm)                 Formation of biolitec
                                                                           Formation of biolitec   IPO at New
                                                                                                    IPO at New
                   -- FDA-approval of green laser                          AG (Deutschland)
                                                                           AG (Deutschland)        Market
                                                                                                    Market
                      FDA-approval of green laser
                   -world’s first diode laser for PDT (630nm)
                   -world’s first diode laser for PDT (630nm)

                                                                    Photosensitizes
                                                                    Photosensitizes
                                                                    Development
                                                                    Development
         Waveguides for
         Waveguides for
         angioplasty
         angioplasty



                               Formation of
                                Formation of                                                         Reorganization of the
                                                                                                     Reorganization of the
                               CeramOptec
                                CeramOptec                                                           biolitec group
                                                                                                     biolitec group
    Formation of
     Formation of              Industries Inc. (USA)
                                Industries Inc. (USA)
    CeramOptec GmbH
     CeramOptec GmbH
    (Deutschland)
     (Deutschland)                                                                 Reorganization of the
                                                                                   Reorganization of the
                                                                                   biolitec group
                                                                                   biolitec group

    Formation of
    Formation of                 Formation of
                                  Formation of                  Formation of
                                                                Formation of
    CeramOptec Inc. (USA)
    CeramOptec Inc. (USA)        CeramOptec Sdn. Bhd.
                                  CeramOptec Sdn. Bhd.          CeramOptec Ltd.
                                                                CeramOptec Ltd.
    – today: biolitec Inc.
    – today: biolitec Inc.       (Malaysia)
                                  (Malaysia)                    (Irland)
                                                                (Irland)


               1988     1989      1990    1991          1993    1995   1996       1998    1999     2000    2001       2002


    3                                                                                                       biomedical technology




                                          ELVeS™ by biolitec
ELVeS™ by biolitec
                     Conclusions
• Laser light constitutes a breakthrough in the management
  of Varicose Veins

• The Endo Laser Vein System by Biolitec represents the
  most complete and flexible system available on the market
  today

• Patient Awareness in the benefit of an ELVeS™ treatment
  is bound to increase driven by social and economical
  (political !) factors

• Patient Attitude based on their perception of a “friendly”
  treatment and the “walk-in / walk-out” possibility thanks to
  the use of laser energy


                     ELVeS™ by biolitec

				
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posted:6/29/2012
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