Agenda of Product Presenta0on. I. Introduc*on II. Laser Physics III. Key Advantages IV. Clinical Data V. Key Takeaways

Transcription

1 Agenda of Product Presenta0on I. Introduc*on II. Laser Physics III. Key Advantages IV. Clinical Data V. Key Takeaways 1

2 Applica0ons of DIOLAS LFD 3000 at a Glance Benign Prostatic Hyperplasia (BPH) Destruction of Stones in Kidney, Bladder and Ureter Tissue-protective Therapy of Strictures and Stenosis of Urethra or Ureter Vaporization of Urothelial Tumours Vaporization of Condylomata and many more Key Advantages: The physician can efficiently and simultaneously, vaporize and coagulate soft tissue even at high-risk patients. Pre-defined programmes enable e.g. the unique stone destruction feature. 2

3 Both Wavelength and Opera0ng Mode Influence Pa0ent Outcome Unique Hardware of DIOLAS LFD 3000 enables excellent vaporization due to high absorption in both water and soft tissue throughout the whole procedure. Patented LFD Mode provides thin layer of coagulation zone, reducing thermal damage to only 1 mm. More Control during the procedure by special fiber probes. 3

4 A New Laser Opera0ng Mode for Strong Vaporisa0on at an Op0mum of Coagula0on Continuous wave is the simplest form of laser light, with typical drawbacks such as carbonization and coagulation. Pulsed lasers emit laser energy by interrupting the continuous beam output, decreasing the heat exposure. Multiple waves of laser light shape the LFD mode s distinct tissue effect: strong vaporization with a 1 mm coagulation zone strong vaporisation with carbonization at the border zones deep coagulation effect by the constant heat exposure less effect at tissue due to the interrupted emission of laser energy reduced zone of coagulation by less heat exposure strong surface vaporisation effect by the constant stream of LFD modified laser light thin coagulation zone of 1 mm that effectively stops bleeding & necrosis Continuous Wave (CW) Pulsed Mode LFD Mode 4

5 Key Advantages: Intelligent Design First Medical Laser worldwide with built-in programmes for the treatment of BPH, Stones, Condylomata and others integrated in one single device Quick and easy selection of all programmes & parameters using the integrated Touch Panel, and power level adjustment using the foot switch Comfortable dimmable red laser pilot light during the procedure no need for expensive special filters for your camera system 5

6 Key Advantages: Intelligent Design Flexible usage of Sidefire and Bare Fibers for a broad range of procedures Low noise level and minimal heat production achieved using an intelligent control system and unique design features Statistical output of all treatment parameters by an external USB stick Eye-safe laser light for less potential complications resulting from laser radiation 6

7 Benefits for the Physician One device for a whole range of procedures, no repeated learning of different handling or user interfaces Shorter treatment time: Efficient vaporization throughout the whole procedure even at large prostates Excellent Coagulation and Haemostasis, much less complications intra- and postoperatively More Control during the procedure due to even ablation and precise absorption of the laser energy. Clear sight without special camera filters 7

8 Benefits for the Hospital Clearly reduced short and longterm costs. Both ablation and enucleation / cutting of tissue are enabled. Bare Fibers are reusable up to 20 times. Shorter patient stay in hospital, day surgery treatment is possible Less maintenance costs compared to Green lasers and other systems No special requirements - the laser works at 230 V / 110 V, without external cooling supplies Eye-safe laser light, no special camera filters needed 8

9 Benefits for the Pa0ent Minimal swelling, inflammation, bleeding, pain intra / postoperatively due to tissue-protective LFD Mode Ideal even for High-Risk Patients. Clinical trial showed less complications, taking of bloodthinning drugs can be continued Regular urination is possible immediately after treatment Shorter convalescence time, shorter stay in hospital 9

10 Overall Benefits DIOLAS LFD 3000 combines best characteristics of all available alternatives The laser is certified to IEC :2005 (DIN EN :2007) Product developed and manufactured in Germany to quality standard EN ISO 13485:2003 Engineered specifically for Urology and Urogynaecology, splash-proof and easy to maintain 10

11 Clinical Data Franziskus Hospital (Charité Medical University, Berlin / Germany) has conducted various trials with special awen*on to treatment of Benign Prosta*c Hyperplasia (BPH), Stones, Strictures, Condylomata and the general use of DIOLAS LFD 3000 as mul*disciplinary laser Results from Clinical Trials confirm high expec*ons, trial is scaled up to mul* - center due to its success Tissue and Pa*ent outcome was analysed by various means: Postopera*ve extrac*on of *ssue by TURP, Histological Analysis Microscopic Views Macroscopic Views 3D Ultrasound Technology Cystoscopy Range of Ques*onnaires and Scores e.g. IPSS, QoL, etc. 11

12 Clinical Data A variety of abstracts, poster presenta*ons and videos are available at present, even further soon to come Presenta*ons had been held at WCE 2009 (World Congress of Endourology, Munich), CEM 2009 (Central European Mee*ng of the European Asssocia*on of Urology, Ljubjana) Abstracts for major events in 2010 were submiwed with further follow- up results: CURy (World Congress on Controversies in Urology, Athens / Greece) EAU (European Associa*on of Urology, Barcelona / Spain) Latest findings confirm all expecta*ons and underlined the use of DIOLAS LFD 3000 even for high- risk pa*ents (e.g. treatment of 96 years old pa*ent without any intra- or post- opera*ve complica*ons) 12

13 Clinical Trial: Treatment of BPH 1 Vaporiza*on of Prosta*c Tissue 2 For a thorough analysis of the penetration depth and the patient outcome, various steps were undertaken: I. Treatment of the BPH Patient II. Extraction of tissue using TURP III. Analysis of penetration depth by micro-/ macroscopic views, histology, cystoscopy and 3D ultrasound Aeer the Treatment 3 Extrac*on of Tissue using TURP for Analysis 4 Analysis of *ssue by various means 13

14 Clinical Trial: Treatment of Stones The stone destruction feature of DIOLAS LFD 3000 was tested under various scenarios regarding stone consistency, using rigid or flexible endoscopes, etc.

15 Clinical Trial: Mul0disciplinary Usage The current efforts of the extended trial is directed towards the use of DIOLAS LFD 3000 even for further indications and specialties, such as paediatric surgery, etc.

16 Key Takeaways DIOLAS LFD 3000 is a unique device which allows the treatment of a very extended range of indications in Urology and Urogynaecology Patient outcome has improved significantly comparing to other current therapies e.g. GreenLight, TURP, HoLAP, etc. The special combination of hardware and treatment mode LFD enables a thin coagulation zone with minimal negative side-effects at 1 mm of penetration depth Further applications of the laser are yet to be explored Device is strongly backed up by convincing findings from clinical trial 16