A patent-protected innovation MOSESTM Technical ... · energy transmission, resulting in more...

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All in one Laser Urology Platform MOSES TM Pulse 120H MOSES TM Pulse 120H WWW.LUMENIS.COM/ SURGICAL LASER CLASS 4 / IV Holmium:YAG Laser: 2.1μm, 6J max, 1300μs pulse max LASER CLASS 3R / Illa DPSS Laser: 532nm, 5mW max, CW VISIBLE AND INVISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION CLASS 4 LASER PRODUCT per IEC 60825-1: 2007 CLASS IV LASER PRODUCT per 21 CFR 1040.10 AND 1040.11 LB - 10032650_B except for deviations pursuant to laser Notice No.50 dated June 24, 2007 AMERICAS San Jose, CA, USA T +1 408 764 3000 +1 877 586 3647 F +1 408 764 3999 EMEA Dreieich Dreieichenhain, Germany T +49 6103 8335 0 F +49 6103 8335 300 Roma (RM), Italy T +39 06 90 75 230 F +39 06 90 75 269 Hertfordshire, UK T +44 20 8736 4110 F +44 20 8736 4119 JAPAN Tokyo, Japan T +81 3 4431 8300 F +81 3 4431 8301 ASIA / PACIFIC Beijing, China T + 86 10 5737 6677 Gurgaon, India T + 91 124 422 07 95 Kowloon, Hong Kong T + 852 217 428 00 F + 852 272 251 51 Lumenis Ltd. Yokneam Industrial Park 6 Hakidma Street P.O.B. 240 Yokneam 2069204, Israel Tel: +972-4-959-9000 Flexible Ureteroscopy PCNL Vaporization A patent-protected innovation revolutionizing urology care MOSES is a groundbreaking, patent-protected pulse delivery technology, that remarkably improves energy transmission, resulting in more efficient lithotripsy and BPH treatments compared to the regular Holmium pulse With shorter lithotripsy procedures and fragmentation times, reduced retropulsion, and more efficient enucleation and vaporization procedures, the MOSES technology sets a new level of innovation for your urology practice Optimized energy transmission 360˚ Urology Innovation % Transmission Distance, mm 30 10 1 0 70 90 50 Regular 2 3 4 Energy transmission vs. working distance - bench test 5,11 A representative case 360˚ HoLEP Parameter Value Wavelength 2.1 um Max Optical Power 120 W Repetition Rate 5-80 Hz Pulse Energy 0.2-6 J Aiming Beam Green. 3 intensity settings and blinking mode Pulse Width Adjustable (Short, Medium, Long) Smart Identification System (SIS) YES Voice confirmation indicating system’s operational status YES Dual Pedal Footswitch YES Fiber & Suction Tube Support Arm Optional Moses Technology YES Dimensions [W / L / H] 47 x 116 x 105 cm 18.5’’ x 45.6 ‘’ x 41.3’’ Case saver mode YES Weight 245 kg / 539 lbs for single phase Electrical 200-240 VAC, <46 Amp, 50/60 Hz Delivery systems Lumenis reusable and single use delivery systems Warranty One year parts and labor Offers a wide range of treatment options, including Benign Prostatic Hyperplasia Kidney stones Bladder stones Ureteral stones Strictures Bladder tumors Biliary stones Gastroenterology procedures Orthopedic procedures ENT procedures Thoracic & Pulmonary procedures Gynecology procedures Risk information The use of the Lumenis Pulse 120H in urology is contraindicated for patients who are unable to receive endoscopic treatments or are intolerant to prolonged anesthesia, as well as for resection or excision of large vascularized organs. Holmium lasers are intended solely for use by physicians trained in the use of the Ho:YAG (2.1 μm) wavelength. Incorrect treatment settings can cause serious tissue damage. The laser should be used only on tissues that are fully observable. See the system user manual for a complete list of contraindications and risks. Technical Specifications References: 1. Mark Cynk, Holmium Laser Enucleation of the Prostate is More Efficient with More Laser Power, abstract #MP7- 01, Moderated Poster Session 7: BPH/LUTS, WCE 2016 2. Beaghler M, Leo M, Gass J, March J, Sandoval S, et al. (2017) Initial Experience with New High Powered 120 W Holmium for Vaporization of the Prostate. Urol Nephrol Open Access J 4(2): 00119. DOI: 10.15406/ unoaj.2017.04.00119 3. Yehudit Kraizer, Shadie Badaan, Moshe Elazar, Haim Epshtein, Uri Shpolansky: Perfused bladder model for simulation of hemostasis control using holmium laser. WCE poster 2014 4. Andonian et al. Double-blinded Prospective Randomized Clinical Trial Comparing Moses and Regular Modes of Holmium Laser Lithotripsy: Preliminary Results. Podium presentation at EAU 2018 5. Elhilali et al. Moses technology in a stone simulator.Can Urol Assoc J. 2018 Apr;12(4):127-130. doi: 10.5489/ cuaj.4797. Epub 2017 Dec 22 6. Elhilali M., Badaan S., Ibrahim A., Andonian S. Use of Moses Pulse Modulation Technology to Improve Holmium Laser Lithotripsy Outcomes: A preclinical study. Journal of Endourology (June, 2017) 7. Khurshid Ghani, Ureteroscopic holmium laser lithotripsy using the Moses technology. EAU 2018 8. I.Colon, I. Grunberger et al., Transurethral Holmium Laser Vaporization of the Prostate (HoLVP): What to Expect on Initial Experience, abstract #MP7-19, Moderated Poster Session 7: BPH/LUTS, WCE 2016 9. Dusting utilizing suction technique (DUST) for percutaneous nephrolithotomy: Use of a dedicated laser handpiece to treat a staghorn stone. Ghani K.R., Roberts W.W. EAU poster 2017 10. A Usability Comparison of Laser Suction Handpieces for Percutaneous Nephrolithotomy. Dauw CA, Borofsky MS, York N, Lingeman JE. J Endourol. 2016 Nov;30(11):1165-1168 11. Bench test results may not necessarily be indicative of clinical performance Moses Lumenis (Germany) GmbH Heinrich-Hertz-Str 3 D-63303 Dreieich-Dreieichenhain GERMANY Tel: +49 (0) 6103 8335 0 Moses TM Technology US patent number - 9895196 B2 PB-2008222 Rev A

Transcript of A patent-protected innovation MOSESTM Technical ... · energy transmission, resulting in more...

All in one Laser Urology Platform

MOSESTM

Pulse 120H

MOSESTM Pulse 120H

W W W. LU M E N I S .C O M / S U R G I CA L

LASER CLASS 4 / IVHolmium:YAG Laser: 2.1μm, 6J max, 1300μs pulse max

LASER CLASS 3R / IllaDPSS Laser: 532nm, 5mW max, CW

VISIBLE AND INVISIBLE LASER RADIATIONAVOID EYE OR SKIN EXPOSURE TO DIRECTOR SCATTERED RADIATIONCLASS 4 LASER PRODUCT per IEC 60825-1: 2007CLASS IV LASER PRODUCT per 21 CFR 1040.10 AND 1040.11

LB -

1003

2650

_B

except for deviations pursuant to laser Notice No.50dated June 24, 2007

AMERICASSan Jose, CA, USAT +1 408 764 3000 +1 877 586 3647F +1 408 764 3999

EMEADreieich Dreieichenhain, GermanyT +49 6103 8335 0 F +49 6103 8335 300

Roma (RM), ItalyT +39 06 90 75 230 F +39 06 90 75 269

Hertfordshire, UKT +44 20 8736 4110 F +44 20 8736 4119

JAPANTokyo, JapanT +81 3 4431 8300F +81 3 4431 8301

ASIA / PACIFICBeijing, ChinaT + 86 10 5737 6677

Gurgaon, IndiaT + 91 124 422 07 95

Kowloon, Hong KongT + 852 217 428 00 F + 852 272 251 51

Lumenis Ltd.Yokneam Industrial Park6 Hakidma Street P.O.B. 240Yokneam 2069204, IsraelTel: +972-4-959-9000

Flexible Ureteroscopy

PCNL

Vaporization

A patent-protected innovationrevolutionizing urology care

MOSES is a groundbreaking, patent-protected pulse delivery technology, that remarkably improves energy transmission, resulting in more efficient lithotripsy and BPH treatments compared to the regular Holmium pulse

With shorter lithotripsy procedures and fragmentation times, reduced retropulsion, and more efficient enucleation and vaporization procedures, the MOSES technology sets a new level of innovation for your urology practice

Optimized energy transmission

360˚ Urology Innovation

% T

rans

mis

sion

Distance, mm

30

10

10

70

90

50Regular

2 3 4

Energy transmission vs. working distance - bench test5,11

A representative case

360˚HoLEP

Parameter Value

Wavelength 2.1 um

Max Optical Power 120 W

Repetition Rate 5-80 Hz

Pulse Energy 0.2-6 J

Aiming Beam Green. 3 intensity settings and blinking mode

Pulse Width Adjustable (Short, Medium, Long)

Smart Identification System (SIS) YES

Voice confirmation indicating system’s operational status

YES

Dual Pedal Footswitch YES

Fiber & Suction Tube Support Arm Optional

Moses Technology YES

Dimensions [W / L / H] 47 x 116 x 105 cm18.5’’ x 45.6 ‘’ x 41.3’’

Case saver mode YES

Weight 245 kg / 539 lbs for single phase

Electrical 200-240 VAC, <46 Amp, 50/60 Hz

Delivery systems Lumenis reusable and single use delivery systems

Warranty One year parts and labor

Offers a wide range of treatment options, including

• Benign Prostatic Hyperplasia• Kidney stones• Bladder stones• Ureteral stones• Strictures• Bladder tumors• Biliary stones• Gastroenterology procedures• Orthopedic procedures• ENT procedures• Thoracic & Pulmonary procedures• Gynecology procedures

Risk information

The use of the Lumenis Pulse 120H in urology is contraindicated for patients who are unable to receive endoscopic treatments or are intolerant to prolonged anesthesia, as well as for resection or excision of large vascularized organs.

Holmium lasers are intended solely for use by physicians trained in the use of the Ho:YAG (2.1 μm) wavelength. Incorrect treatment settings can cause serious tissue damage. The laser should be used only on tissues that are fully observable.

See the system user manual for a complete list of contraindications and risks.

Technical Specifications

References: 1. MarkCynk,HolmiumLaserEnucleationoftheProstateisMoreEfficientwithMoreLaserPower,abstract#MP7- 01,ModeratedPosterSession7:BPH/LUTS,WCE2016

2. BeaghlerM,LeoM,GassJ,MarchJ,SandovalS,etal.(2017)InitialExperiencewithNewHighPowered 120WHolmiumforVaporizationoftheProstate.UrolNephrolOpenAccessJ4(2):00119.DOI:10.15406/ unoaj.2017.04.00119

3. YehuditKraizer,ShadieBadaan,MosheElazar,HaimEpshtein,UriShpolansky:Perfusedbladdermodelfor simulationofhemostasiscontrolusingholmiumlaser.WCEposter2014

4. Andonianetal.Double-blindedProspectiveRandomizedClinicalTrialComparingMosesandRegularModes ofHolmiumLaserLithotripsy:PreliminaryResults.PodiumpresentationatEAU2018

5. Elhilalietal.Mosestechnologyinastonesimulator.CanUrolAssocJ.2018Apr;12(4):127-130.doi:10.5489/ cuaj.4797.Epub2017Dec22

6. ElhilaliM.,BadaanS.,IbrahimA.,AndonianS.UseofMosesPulseModulationTechnologytoImproveHolmium LaserLithotripsyOutcomes:Apreclinicalstudy.JournalofEndourology(June,2017)

7. KhurshidGhani,UreteroscopicholmiumlaserlithotripsyusingtheMosestechnology.EAU2018

8. I.Colon,I.Grunbergeretal.,TransurethralHolmiumLaserVaporizationoftheProstate(HoLVP):WhattoExpect onInitialExperience,abstract#MP7-19,ModeratedPosterSession7:BPH/LUTS,WCE2016

9. Dustingutilizingsuctiontechnique(DUST)forpercutaneousnephrolithotomy:Useofadedicatedlaser handpiecetotreatastaghornstone.GhaniK.R.,RobertsW.W.EAUposter2017

10. AUsabilityComparisonofLaserSuctionHandpiecesforPercutaneousNephrolithotomy.DauwCA,Borofsky MS,YorkN,LingemanJE.JEndourol.2016Nov;30(11):1165-1168

11. Benchtestresultsmaynotnecessarilybeindicativeofclinicalperformance

Moses

Lumenis (Germany) GmbHHeinrich-Hertz-Str 3 D-63303Dreieich-Dreieichenhain GERMANYTel: +49 (0) 6103 8335 0

MosesTMTechnologyUSpatentnumber-9895196B2

PB-2

0082

22 R

ev A

Redefining Holmium LaserBPH Treatments

MOSES Technology – The new era in Holmium laser Lithotripsy

State of the art fibers and accessories

MOLEP - MOSESTM Laser Enucleation of the ProstateThe new generation of HoLEP

MOSES Vaporization – Acceleration in hand

Improved coagulation

Leverage the power of the MOSES P120H for a more efficient tissue removal, leading to 20% increase in enucleation rate. The enhanced enucleation efficiency results in improved intraoperative vision and cleaner dissection of the capsular plane.1

The MOSES technology shows superior vaporization rate and efficiency compared to regular pulse, indicating potential reduction in procedure time.11

Control hemostasis and keep bleeding minimal with the advanced pulse reshaping technology and customized dual pedal of the MOSES Pulse 120H. 2,3

“The MOSES technology has great potential in improving the efficiency of enucleation procedures and also enabling a faster learning curve.

In my initial clinical experience, I found that there was a smoother cutting effect, excellent hemostasis and improved visibility. Additionally, the enhanced vapor bubble significantly assists in separating the adenoma from the capsule, resulting in better orientation in the plane.”

Prof. Ivano Vavassori, Azienda Ospedaliera Ospedale Treviglio Caravaggio, Italy

Be it kidney, ureteral or bladder stone – the MOSES Technology provides a 360˚ lithotripsy solution for flexible ureteroscopy, PCNL and mini PCNL

Shorter proceduresAs shown in a randomized clinical trial, the MOSES Technology reduces procedure time by 20%, making your treatments faster and more efficient.4,5

Limited retropulsionWith 60% less retropulsion, you can minimize the incidents of ureteral stone migration into the kidney.You may also avoid chasing the stones in the bladder or kidney.4,5,6

Enhanced fragmentationMOSES optimized energy transmission makes every shot count, thus reducing your fragmentation time by 25%.4,5

reduction

%

reduction

20%

reduction

60%

reduction

25%

Leave no stone behind

Vaporize tissue in full contact

Focus on what matters during PCNL

Advanced ball-shaped tip enables a smooth initial insertion of the Moses 200 D/F/L through a flexible scope, and designed to minimize potential scope damage.Moses 200 D/F/L flexible fiber is designed to minimize scope deflection loss, allowing to reach difficult-to-access stone locations.6,11

If the stone is hard to reach, just use the MOSES Distance mode, optimized to deliver energy at a distance, allowing you to reach stones in challenging locations.7

Xpeeda™ D/S/L side firing fiber is designed to deliver increased energy transmission and enables work in full contact mode without causing deep tissue charring.2,8

Suction hand-piece allows simultaneous laser-lithotripsy and aspiration of stone fragments.9,10

*Pending CE mark

Moses™ 200 D/F/L Legacy Fiber

Vaporization rate - Bench Test11

Vapo

rizat

ion

rate

- Fo

ld C

hang

e 11

Aver

age

retro

puls

ion

(Lik

ert s

cale

0-3

)MosesRegular

2.5

2

1.5

1

0.5

0

Moses Regular

1.2

1

0.8

0.6

0.4

0.2

0

Average retropulsion measured on a scale of 0-3 (0 – No retropulsion 3 – Major retropulsion)

Deflection loss of flexible scope - bench test10

A representive case

Moses 200 D/F/L Equivalent 200 fiber

Defl

ectio

n lo

ss (d

egre

e)

16

14

12

10

8

6

4

2

0