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HARMONI® Modular IOL System
Paul McLean
President and CEO
4 May 2017
1
HARMONI Modular IOL Design
The base provides a stable foundation:
• Reliable ELP
• Optimized rotational stability
• Enhanced centration
The optic enables versatile control:
• Safe and easy exchange
• Upgradeability
• Refractive care for the patient’s lifetime
Mission: Complete confidence in surgical outcomes
without added costs or change to routines
The HARMONI modular IOL is an investigational device and is not approved for use in the United States
HARMONI Development at a Glance
2012
2
Technology
development
FIH Trial
#1 Innovation
3 new trials
CE Mark
IDE Submission
Confirmed:
• Stable
• Replaceable
• Versatile
• Easy
Pivotal Trial
250+ patients in trials
Data out to 3 years
Trial Enrollment
HUD for Pediatric
• Stable
• Replaceable
• Versatile
• Easy
Key clinical learnings
• HARMONI is safe to implant and exchange
• Visual performance rivals traditional IOLs
• HARMONI offers best in class stability
• Outcomes can be fine tuned with exchange
2013
2014
2015
2016
2017
2018
The HARMONI modular IOL is an investigational device and is not approved for use in the United States
Best-in-class stability
Rotational Stability
• HARMONI measured from Day 0
• Standard photographic assessment
• For every degree off-axis you lose ~3% of the
astigmatic correction
ACD Stability
• IOL movement is major cause of refractive surprise
• 200 microns movement ~0.25D refractive change
• Movement less than 200 microns = axially stable
33%
77%
0%
20%
40%
60%
80%
100%
Change Less than 0.2mm D0-1M post op
Percentage of IOLs that were axially stable
AcrySof HMIOL
Rotational Stability of HARMONI compared to AcrySof and
Tecnis
Product Mean/SD
(degrees)
Rotation
<5
o
Rotation
<10
o
HARMONI (n=85) 2.5 (2.0) 98% 99%
AcrySof* 3.4 (3.0) 82% 97%
Tecnis (day 1)* 1.4(6.1) 94% 97%
* Package insert data
3
The HARMONI modular IOL is an investigational device and is not approved for use in the United States
ClarVista Highlights
4The HARMONI modular IOL is an investigational device and is not approved for use in the United States
• Top tier IOL performance
• Best-in-class stability
• Safe and easy exchange
Accelerate AT IOL utilization
 IOL performance you can count on, versatility and control you crave
 Technology for a lifetime
– Safe & easy IOL replacement and upgrades
– One platform, all patients
HARMONI® Modular IOL System
For more information about the HARMONI Modular IOL please contact:
Paul McLean
pmclean@clarvistamedical.com
www.clarvistamedical.com

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Ophthalmology Innovation Showcase 2 - ClarVista Medical

  • 1. HARMONI® Modular IOL System Paul McLean President and CEO 4 May 2017
  • 2. 1 HARMONI Modular IOL Design The base provides a stable foundation: • Reliable ELP • Optimized rotational stability • Enhanced centration The optic enables versatile control: • Safe and easy exchange • Upgradeability • Refractive care for the patient’s lifetime Mission: Complete confidence in surgical outcomes without added costs or change to routines The HARMONI modular IOL is an investigational device and is not approved for use in the United States
  • 3. HARMONI Development at a Glance 2012 2 Technology development FIH Trial #1 Innovation 3 new trials CE Mark IDE Submission Confirmed: • Stable • Replaceable • Versatile • Easy Pivotal Trial 250+ patients in trials Data out to 3 years Trial Enrollment HUD for Pediatric • Stable • Replaceable • Versatile • Easy Key clinical learnings • HARMONI is safe to implant and exchange • Visual performance rivals traditional IOLs • HARMONI offers best in class stability • Outcomes can be fine tuned with exchange 2013 2014 2015 2016 2017 2018 The HARMONI modular IOL is an investigational device and is not approved for use in the United States
  • 4. Best-in-class stability Rotational Stability • HARMONI measured from Day 0 • Standard photographic assessment • For every degree off-axis you lose ~3% of the astigmatic correction ACD Stability • IOL movement is major cause of refractive surprise • 200 microns movement ~0.25D refractive change • Movement less than 200 microns = axially stable 33% 77% 0% 20% 40% 60% 80% 100% Change Less than 0.2mm D0-1M post op Percentage of IOLs that were axially stable AcrySof HMIOL Rotational Stability of HARMONI compared to AcrySof and Tecnis Product Mean/SD (degrees) Rotation <5 o Rotation <10 o HARMONI (n=85) 2.5 (2.0) 98% 99% AcrySof* 3.4 (3.0) 82% 97% Tecnis (day 1)* 1.4(6.1) 94% 97% * Package insert data 3 The HARMONI modular IOL is an investigational device and is not approved for use in the United States
  • 5. ClarVista Highlights 4The HARMONI modular IOL is an investigational device and is not approved for use in the United States • Top tier IOL performance • Best-in-class stability • Safe and easy exchange Accelerate AT IOL utilization  IOL performance you can count on, versatility and control you crave  Technology for a lifetime – Safe & easy IOL replacement and upgrades – One platform, all patients
  • 6. HARMONI® Modular IOL System For more information about the HARMONI Modular IOL please contact: Paul McLean pmclean@clarvistamedical.com www.clarvistamedical.com