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

0

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

8

12

16

CDELenSx

9.35

11.52

12.71

13.83

8

12

16

CDELenSx

Lower 42%

Lower 50%

Lower 32%

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6.67

5.476.416.51

0

4

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

Foto 07.09.11 17 37 24.jpeg

Foto 07 09 11 17 34 15

10/11/2011LenSx Lasers, Inc. CONFIDENTIAL

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Foto 07.09.11 17 34 15


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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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lensx lasers, inc. 10/11/2011 - freevis

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