LenSx Lasers, Inc. 10/11/2011 - FreeVis
Transcript of LenSx Lasers, Inc. 10/11/2011 - FreeVis
LenSx Lasers, Inc. 10/11/2011
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Michael C. KnorzMedical Faculty Mannheim, University of Heidelberg
Mannheim, Germany
History of Cataract Surgery
Sushruta performed couching 800 BC• Sushruta Samhita (सु तुसंिहता)
Jaques Daviel invented ECCE 1747Si H ld Ridl i l t d fi tSir Harold Ridley implanted firstposterior chamber IOL 1950Charles Kelman introducedphacoemulsification in 1967
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Charles Kelman, 1967
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Visual Outcomes• Distance correction predictability
50% that of LASIK• Astigmatism Correction• Final IOL Position
Limitations of Phaco Surgery
Safety• Complications 10x LASIK• Ultrasound associated with:
- corneal burn- corneal edema- endothelial cell loss(1,2)
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1Pereira et al. JCRS 2006 Oct;32(10):1661-6 2Park et al. Ophthalmic Surg Lasers Imaging. 2010 Mar-Apr;41(2):236-41
Phaco 1967 - What is next ?
Laser Refractive Cataract Surgeryusing a femtosecond laser !• 2008: first surgery performed in Budapest by
Zoltan Nagy using Alcon LenSx laserZoltan Nagy using Alcon LenSx laser
• 2009: Alcon LenSx first laser to receive FDA approval for cataract surgery
• 2010: first surgery in the US performed byStephen Slade using Alcon LenSx laser
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OVERVIEW OF LASER SYSTEMS
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Laser Systems
Alcon LenSx (CA, USA)
OptiMedica CATALYS (CA, USA)
L AR (FL USA)LensAR (FL, USA)
Technolas VICTUS (Munich, GER)
Others
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Alcon LenSx
Femtosecond laserOCT
510K approvalsppCE marked• Capsulorhexis
• Liquefaction
• Corneal incisions (AK !)
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OptiMedica CATALYS
Liquid Optics InterfaceOCT Femtosecond laser
Not approved in USCE-marked for• Capsulorhexis
• Lens fragmentation
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LensAR Laser
Initially designed to soften lens tocorrect presbyopiaPicosecond laser
Scheimpflug cameraScheimpflug camera,not real-time
510K approval for• Capsulotomy
• Lens fragmentation
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Technolas VICTUS
Femtosecond laserOnly combined platform• Flaps
• Corneal transplants• Corneal transplants
• AK
• INTRACOR
• Not approved:• Capsulorhexis and liquefaction
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Other Systems
AMO IntraLase iFS• Combined system
• Astigmatic cuts• Astigmatic cuts
• Incisions
• Capsulorhexis?
• Fragmentation?
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My Personal Experience
AlconAlcon LenSx LenSx laserlaser
SurgerySurgery performedperformed in Budapest, in Budapest, HHHungaryHungary
Alcon LenSx Alcon LenSx laserlaser in Mannheim in Mannheim sincesince77--20112011
LenSx Laser – User Interface
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Why Laser Refractive Cataract Surgery ?
Capsulorhexis
Lens fragmentation / liquefaction
Corneal incisions
Astigmatism correction
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CAPSULORHEXIS
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Ideal Capsulorhexis
Reproducible size and shape, wellcentered
Current Manual Capsulorhexis
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Too large Too small Irregular shape Off center
No capsule-IOL overlap
IOL tilt
Phimosis
Difficult phaco maneuver
IOL tilt
IOL decentration
IOL decentration
Edge catches visual axis
Laser Capsulorhexis
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LenSx Laser Capsulorhexis
60
70
80
90
100
mple (%)
Capsulotomy Diameter Accuracy(Absolute difference between Attempted and Acheived)
Laser (n=60)
Manual
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Only 10% of manual rhexis achieved diameter accuracy of +/- 0.25mm
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10
20
30
40
50
0 <=0.25 <=0.5 <=0.75 <=1.0 <=1.25 <=1.5
Percent of Sa
Diameter Error (mm)
Manual (n=60)
LenSx Laser Capsulorhexis
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Manual capsulorhexis LenSx laser capsulorhexis
How strong is the Laser CCC ?
Nagy Z, Takacs A, Filkorn T, Sarayba MInitial Clinical Evaluation of an IntraocularFemtosecond Laser in Cataract SurgeryJ Refract Surg 2009; 25:1053-1060 • 8 procine eyes each group, 5-mm CCC using corneal mark
CCC t t h d ith li ti l l t d• CCC stretched with calipers, ratio calculated
Laser CCC• Ratio 2.13 +/-0.03 (range, 2.07 – 2.17
Manual CCC• Ratio 1.98 +/-0.08 (range, 1.84 – 2.09)
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Capsulorhexis and ELP
Prospective study• 4.5 mm LenSx laser capsulorhexis
• 4.5 mm manual capsulorhexis
ACD and AL measured using LenStarOptical Biometry
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ELP - Results
Statistically Significant Difference in Variance Between the Two Groups
* F Test P < 0.05
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0,000
0,050
0,100
0,150
0,200
0,250
1 Month
ACD / AL Ratio
Manual
LenSx
Reduced Variability in Effective Lens Position (ELP) in LenSx Laser Group
LENS FRAGMENTATION / LIQUEFACTIONQ
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Liquefy and Chop Pattern
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Liquefy• Used for softer lenses (to Grade 2)• Number of cylinders customizable
Chop• Generally used for harder lenses (grade 3, 4+)• Number of cuts customizable
Hybrid Technique
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Hybrid Pattern
• Combination of liquefaction and chop patterns
• Efficient for all cataract grades
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• Rapid lens removal with minimal phaco required
• Preferred pattern for surgeons going forward
Hybrid Pattern• Used for all Cataract Grades• # Cuts/Cylinders Customizable
Phaco vs LenSx Laser
43% reduction
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51% reduction
Cummulative Dissipated Energy (CDE)
9.35
11.52
12.71
13.83
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12
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CDELenSx
9.35
11.52
12.71
13.83
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12
16
CDELenSx
Lower 42%
Lower 50%
Lower 32%
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6.67
5.476.416.51
0
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All Soft Moderate Dense
Cataract Grade
Manual6.67
5.476.416.51
0
4
All Soft Moderate Dense
Cataract Grade
Manual
Phaco vs LenSx Laser
28% decrease in endothelial cell loss in Laser group compared to Phaco group (one month postop)
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CORNEAL INCISIONS
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Manual Corneal Incisions
Wound architecture limited by hand-held instruments, manual incisions- imprecise tunnel length and geometry
Frequently require stromal hydration to seal
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Can result in cascading intraoperative difficulties- fluid control, anterior chamber maintenance
Recent literature suggests an increased incidence of post-op infection1
Incisions may be unstable at low IOPs2
LenSx Laser Corneal Incisions
Complete flexibility to customize architecture of all corneal incisions
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• 3D visualization • Predictable Accuracy• Precise, self-sealing wound design
LenSx Laser Corneal Incision
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PostOp OCT image of LenSx 2-plane corneal incision
Laser Incisions
Laser incisions are more architecturally reproducible and have greater self-sealing properties
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ASTIGMATISM CORRECTION
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Manual Arcuate Incision
Traditional, handheld Diamond Knife
Manually executed by “tracing”
corneal marks
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Inconsistent depth control
Poorly predictable
LenSx Laser Arcuate Incisions
Image-guided with 3D visualization
• Fully Customizable and adjustable
• Refractive incisions are no longeran art form. They are a science.
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• Place Desired Incisions:
• EXACT Size
• EXACT Place
• EXACT Depth
• Every Time
Astigmatic Outcome
64%
71%
93%
100% 100%
86%
93%
100%
60%
80%
100%
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50%
0% 0%0%
20%
40%
≤0.50 ≤0.75 ≤1.00 ≤1.25 ≤1.50 ≤2.00 >2.00
Astigmatism (D)
Pre Op (∆Ks)Post Op (MR Cyl.)
Double-Angle Plot
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Pre OP (n=14)• Keratometric Centroid: +0.08D @ 17° ± 0.59D, ρ = 1.82
Post OP (n=14)• Refractive Centroid: +0.26D x 178° ± 0.23D, ρ =
0.45
MARKET POTENTIAL
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Issues to Consider
Can the market support another premium technology ?
Do we need a laser to improve our clinical o e eed a ase to p o e ou c caperformance ?
Will our patients understand and embrace the technology ?
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Refractive Cataract Surgery
Global Cataract Surgery ForecastGlobal Cataract Surgery Forecast
Global Cataract Market
Data: Market Scope 2009 Report
547 762 940 1,171 1,443 1,777 2,183 2,629
Laser Refractive Cataract Surgery
A Market Fueled by Baby Boomers
- Educated
- Demanding
- Financially Secure
Embracing Demand Driven Healthcare
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- Embracing Demand-Driven Healthcare
The Expectation
- A Better Experience
- A Predictable Procedure
- A Better Value Proposition
Surgeon Expectations
Alcon LenSx technology provides the surgeon:
• Known benefits of femtosecond technology
- Improved accuracy of all incisions
- Predictability at every step
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• True image-guided intraocular surgery
- Opportunity to create optimal wound architecture
- Precise capsulotomy
• Expanded revenue stream
- A strong value proposition
- A message that easily resonates with patients and staff
Patient Expectations
Alcon LenSx technology provides the patient:
Perceived benefits of a laser procedure
- Computer controlled precision
- Procedural predictability
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A comprehensive, advanced technology approach to lens replacement surgery
A truly premium, value-added surgical experience
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10/11/2011LenSx Lasers, Inc. CONFIDENTIAL
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Welcome to the Future !
Laser Refractive Cataract Surgery
A combination of premium technologies
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A combination of premium technologies
A premium opportunity for surgeons and patients
Laser Refractive Cataract Surgery will increase safety and efficacy of cataract removal
Laser fragmentation requires less phaco power to complete the nucleus removal
Conclusions
complete the nucleus removal
The reduction in ultrasound energy during Laser Refractive Cataract Surgery preserves endothelial cells
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Outcome predictability will improve as the laser replaces most of the manual, imprecise steps of cataract surgery
A laser created, perfectly centered capsulotomy improves effective lens position (ELP) and thereby
Conclusions
improves effective lens position (ELP) and thereby refractive predictability
Laser-created corneal incisions to correct astigmatism deliver a new level of refractive cataract surgery
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