IntraLase Technology

IntraLase Technology
Truly Customizable Architecture
The IntraLase FS and iFS Laser Systems are ophthalmic
surgical lasers indicated for use in patients undergoing surgery or
treatment requiring the initial lamellar resection of the cornea.
For safety information, please see inside.
IntraLase Technology:
Two Innovative Femtosecond Laser Platforms
iFS Advanced Femtosecond Laser System
AMO’s latest laser platform has all the features of the IntraLase FS System, plus:
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Increased speed
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Enhanced flap-customization capabilities
– Inverted bevel-in side cut
– Elliptical flap option
– Advanced corneal capabilities
IntraLase FS Femtosecond Laser System
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Provides unparalleled uniformity and precision, biomechanical stability and an unsurpassed safety profile
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Enables physicians to customize flap parameters such as depth, edge angle and centration
Both femtosecond laser systems embody IntraLase Technology, an essential component of the iLASIK Solution.
The IntraLase FS and iFS Laser Systems are ophthalmic surgical lasers
indicated for use in patients undergoing surgery or treatment requiring the initial
lamellar resection of the cornea. Contraindications may include corneal edema,
glaucoma, and keratoconus. Risks and complications may include corneal pain,
flap tearing, and epithelial ingrowth. Patients are requested to consult with their
eye care professional for a complete listing of contraindications and risks. U.S.
Federal Law restricts this device to sale, distribution, and use by or on the order
of a physician or other licensed eye care practitioner.
iFS Femtosecond Laser
IntraLase FS Femtosecond Laser
Advanced Capabilities from the
iFS Femtosecond Laser
The iFS Laser System has all the features of the IntraLase FS System, plus increased speed and enhanced
flap-customization capabilities that include:
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Inverted bevel-in side cut up to 150° for optimal biomechanical stability1
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Elliptical flap option to maximize stromal bed exposure
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Tighter spot separation provides smoother stromal beds and a virtually effortless flap lift2
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Lower energy per pulse, which may reduce tissue response and inflammation
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Higher repetition rate and faster procedure time, which enhance patient comfort and confidence
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High-resolution video microscope for maximum surgeon comfort
Inverted Bevel-In Side Cut
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Increased flap adhesion post-operatively for optimal wound healing1
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3x more flap stability (150° side cut) vs. microkeratome during flap lift1
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Significantly reduced flap gutter3
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Improves severed nerve apposition3
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Less of a reduction in corneal sensitivity3
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Fewer dry eye signs and symptoms than with the 30° side cut3
30° side cut slows nerve regeneration
post-operatively3
Inverted bevel-in side cut, customizable to 150°, promotes flap
replacement, positioning and adhesion for optimal biomechanical
stability of the post-LASIK cornea1
150° side cut promotes faster nerve
regeneration post-operatively3
“With the added speed of the iFS Laser, I am now placing tighter pulses and
bevel-in edges, allowing me to create flaps that are faster and easier to lift,
with smoother beds and increased stability.”
—C
hristopher L. Blanton, MD
Inland Eye LASIK
Ontario, CA
Elliptical Flap Enhances Surgical Options
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Distributes forces symmetrically to the elliptical cornea
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oves the hinge peripherally to maximize stromal bed exposure for full delivery of excimer ablation and
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reduces chance of ablating the hinge2
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Allows use of a wider hinge angle2
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May spare some corneal collagen fibers to enhance biomechanical stability2
Elliptical Flap
Round Flap
Greater Biomechanical Stability, Smoother Stromal
Beds and Faster Visual Recovery
IntraLase Flaps Result in Greater Biomechanical Stability
uStronger
flaps through faster wound healing1
uIncreased
adhesion post-operatively1
3-Month Comparative Measurement
of Flap Tensile Strengths1
uInverted
bevel-in side cut promotes faster
nerve regeneration post-operatively3
Peak Force Measured
Grams of force required to lift
700
600
3x stronger
500
than AMADEUS
Microkeratome
400
2x stronger
than AMADEUS
Microkeratome
300
200
100
0
AMADEUS
Microkeratome
IntraLase iFS Laser
70˚ Side Cut
IntraLase iFS Laser
140˚ Side Cut
In New Zealand White rabbit eyes, three groups of flaps were created with either
the AMADEUS™ microkeratome, iFS Laser 70° side-cut angle, or iFS Laser
140° side-cut angle. At 3 months, a force gauge was attached to a curved
lens and pulled perpendicularly until the flap dehisced and peak force could
be measured. Note the IntraLase FS Laser has a side-cut angle up to 90°.
Central Corneal Sensation3
6
5.7 5.7
140∞ Side Cut
Mean Score
5
P < .001
30∞ Side Cut
4.4
4
3
2
2.1
1
0
0.4 0.3
Baseline
Day 1
0.2 0.2
Day 7
0.8
0.6
Day 30
Day 90
At Day 90, eyes with the 140° side cut had significantly
more central corneal sensation than eyes with the 30°
side cut
Similarly, eyes with the 140° side cut had significantly
more superior corneal sensation than eyes with the 30°
side cut (P<.001)
Significantly Smoother Stromal Beds4
IntraLase Technology results in significantly higher-quality stromal beds than are possible with the FEMTO LDV™.
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Stromal bed roughness with the iFS Laser was 39.55 nm
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Stromal bed roughness with the IntraLase FS Laser was 41.20 nm
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Stromal bed roughness with the Ziemer FEMTO LDV Laser was 42.87 nm
iFS Laser
IntraLase FS Laser
Ziemer FEMTO LDV Laser
(9x)
(9x)
(9x)
(300x)
(300x)
(300x)
Images of the IntraLase FS Laser and Ziemer FEMTO LDV Laser are provided by Daniel S. Durrie, MD
Images of the iFS Laser are provided by Melvin A. Sarayba, MD
IntraLase Technology Showed Faster Visual Recovery 5
At all time points measured, the percentage of eyes that recovered at post-operative UCVA of 20/20 or better was
significantly higher in the femtosecond group.
Percentage of eyes that recovered at
uncorrected visual acuity of 20/20 or better
Faster Visual Recovery 5
100%
Femtosecond
Microkeratome
95%
90%
75%
96%
93%
93%
93%
89%
85%
80%
96%
86%
83%
1 Day
1 Week
1 Month
Follow-up
3 Months
A retrospective analysis of
1,000 eyes treated with the
IntraLase FS Laser and
1,000 eyes treated with a
mechanical microkeratome
(N=2,000)
Enhanced Safety with Unparalleled
Uniformity and Precision
With over 3.5 million procedures and counting, “all-laser” IntraLase Technology offers numerous safety advantages
over microkeratome technology, both during flap creation and post-operatively.
Flap Creation Safety Advantages
Reduces or eliminates several complications, including:6-8
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Buttonhole or free flaps
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Irregular flaps
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Microperforations
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Decentered flaps
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Epithelial defects
Furthermore, higher laser speed reduces time under suction,
which means:2
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Less risk of suction break
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Less time during which the eye experiences elevated
intraocular pressure
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Less potential for subconjunctival hemorrhages
Unparalleled Uniformity and Precision Give You the Ability to Precision-Design
Your Patients’ Intracorneal Architecture
The unique computer-controlled laser system enables surgeons to create thin, planar flaps with a uniform mean
thickness of 112 ± 5 µm and an average standard deviation of as little as 4 µm within each flap,9 maximizing residual
bed and potentially producing a more stable post-LASIK cornea.
Average SBK Flap Thickness
Microns
109
113
110
114
113
111
111
114
111
113
110
113
110
110
113
120
113
140
112
Overall
Average
SD + 5 µm
160
100
80
60
40
20
0
-4 -1 +1 +4
-4 -1 +1 +4
-4 -1 +1 +4
Millimeters
-4 -1 +1 +4
N=25
Courtesy of Jason Stahl, MD, Durrie Vision, Overland Park, KS, USA
Advanced Corneal Capabilities with
IntraLase Technology
IntraLase Technology brings advanced corneal options within reach, including intrastromal ring implantation and
channels, and IntraLase Enabled Keratoplasty.
Cut Segments
Create Unlimited Customized Incisions
Anterior
Side Cut
For optimized tissue resection, physicians can customize
parameters such as channel width, offset, depth, spot
separation, line separation and energy; side-cut radius,
angle and energy; and layer separation. This advanced
laser system enables the user to perform the following
cut segments:
uIncisions
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Ring
Lamellar Cut
for channels or rings
Full Lamellar Cut
Posterior
Side Cut
Full Thickness
Anterior Side Cut
Ring
Lamellar Cut
Anterior side cut
uPosterior
uLamellar
side cut
cut (full or ring)
Femtosecond Technology Revolutionizes
Corneal Transplants with IntraLase
Enabled Keratoplasty
IntraLase Technology is the first in the world used to
create innovative shaped corneal incisions for full-thickness
corneal transplants.
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Precisely shaped angled edges fit snugly to improve alignment10
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Provides a smooth corneal contour with greater surface area
to speed wound healing10
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IntraLase-cut grafts have better wound integrity and seven
times higher resistance to wound leakage10
Three-month post-operative optical coherence
tomography image of cornea in cross-section,
clearly showing the perfect match of the zig-zag
incisions in the donor and host cornea11
Example Pattern Configurations
Top Hat
Anterior Side
Zig-Zag
Mushroom
Half Zig-Zag
Christmas Tree
The IntraLase FS and iFS Laser Systems are ophthalmic surgical lasers indicated for use in the creation of a lamellar cut/resection
of the cornea for lamellar IntraLase Enabled Keratoplasty (IEK), for the creation of a penetrating cut/incision for penetrating IEK,
and for corneal harvesting. Contraindications may include any corneal opacity adequately dense to obscure visualization of the iris,
descemetocoele with impending corneal rupture, previous corneal incisions that might provide a potential space into which the
gas produced by the procedure can escape, and cornea thickness requirements that are beyond the range of the system. Patients
are requested to consult with their eye care professional for a complete listing of the contraindications and risks. U.S. Federal Law
restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care professional.
“
“We’ve done some studies with the iFS Femtosecond Laser. It’s like night and
day compared to anything else I’ve ever used.”
—K
erry D. Solomon, MD
Carolina Eyecare Physicians, LLC
Mt. Pleasant, SC
“These studies were statistically significant and certainly suggest that the
inverted bevel-in side cut design of the iFS flap is far more stable than
mechanically created flaps. The ability to precisely create truly customized
flaps for every patient further validates the iLASIK Procedure.”
—P
rof. Dr. Michael C. Knorz
FreeVis LASIK Zentrum
Universitätsklinikum Mannheim, Germany
“Corneal surgery is rapidly evolving towards disease-specific surgery. IEK
is part of this evolution; breakthrough technology allows complex incision
patterns which are reproducible between donor and recipient, or eye
bank and doctor. IEK also enables surgeons to choose the pattern
most consistent with a patient’s underlying problem.”
—F
rancis W. Price, Jr., MD
Price Vision Group
Indianapolis, IN
“The bottom line is that IntraLase Technology is a tried and true system.
It works, it’s consistent and it gets excellent results. It’s years ahead of
any of the other platforms.”
“
—L
ouis Probst, MD
TLC The Laser Eye Centers
Chicago, IL
The iLASIK Solution
Innovative Technologies Delivering Exceptional Results
The iLASIK Solution, available exclusively from AMO, is the combination of IntraLase and Advanced
CustomVue Technologies. This unique blend of technologies sets a new standard for laser vision correction.
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u
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Beyond 20/20.
The iLASIK Technology Suite provides a truly customized treatment,
helping you take more of your patients beyond 20/20 vision*
Good Enough for NASA and Your Patients.
NASA astronauts and U.S. fighter pilots can have laser vision correction
surgery today because of the exclusive, validated safety and precision
performance of iLASIK Technologies
Leading Innovation.
With over 20 years of innovation, more than 15 million procedures
worldwide and the broadest range of FDA wavefront-guided LASIK
approvals, iLASIK Technologies are the true industry leaders
Unsurpassed Service, Support and Value.
Our award-winning† service and post-sales support enhance the
value of your investment in the premium iLASIK Platform by
maximizing reliability, quality and patient outcomes
For more information and to contact an AMO representative,
go to www.amo-ilasik.com or call 1-877-AMO-4LIFE.
Laser assisted in-situ keratomileusis (LASIK) can only be performed by a trained ophthalmologist and for specified reduction
or elimination of myopia, hyperopia, and astigmatism as indicated within the product labeling. Laser refractive surgery is
contraindicated for patients: a) with collagen vascular, autoimmune, or immunodeficiency diseases; b) who are pregnant or
nursing women; c) with signs of keratoconus or abnormal corneal topography; d) who are taking one or both of the following
medications: Isotretinoin (Accutane®) and Amiodarone hydrochloride (Cordarone®). Potential side effects to laser refractive
surgery may include glare, dry eye, as well as other visual anomalies. LASIK requires the use of a microkeratome that cuts a flap
on the surface of the cornea, potential side effects may include flap related complications. Patients are requested to consult with
their eye care professional and Patient Information Booklet regarding the potential risks and benefits for laser refractive surgery,
results may vary for each individual patient.
Restricted Device: U.S. Federal Law restricts this device to sale, distribution, and use by or on the order of a physician or
other licensed eye care practitioner. U.S. Federal Law restricts the use of this device to practitioners who have been trained in
its calibration and operation and who have experience in the surgical treatment and management of refractive errors.
*20/16 results delivered with excimer laser; clinical studies sent to the FDA via P930016 supplement 021.
AMO won the 2010 Omega NorthFace ScoreBoardSM Award for delivering world-class customer service and consistently exceeding customer expectations.
This is the ninth straight year AMO has won the award.
†
References
1. Knorz MC, Vossmerbaeumer U. Comparison of flap adhesion strength using the AMADEUS microkeratome and the IntraLase iFS femtosecond laser in rabbits. J Refract Surg. 2008;24(9):875-878.
2. Binder PS. AMO’s new iFS advanced femtosecond laser: faster, safer, more versatile. Refractive Eyecare. 2008.
3. Donnenfeld E. Preservation of corneal innervation with femtosecond laser inverted sidecut flaps. Invest Ophthalmol Vis Sci. 2010 51: E-Abstract 2855.
4. Data on file. Study conducted by Melvin A. Sarayba, MD.
5. Tanna M, Schallhorn SC, Hettinger KA. Femtosecond laser versus mechanical microkeratome: a retrospective comparison of visual outcomes at 3 months. J Refract Surg. 2009;25(7 Suppl):S668-S671.
6. Binder PS. One thousand consecutive IntraLase laser in-situ keratomileusis flaps. J Cataract Refract Surg. 2006;32(6):962-969.
7. Stonecipher K, Ignacio TS, Stonecipher M. Advances in refractive surgery: microkeratome and femtosecond laser flap creation in relation to safety, efficacy, predictability, and biomechanical
stability. Curr Opin Ophthalmol. 2006;17(4):368-372.
8. Kezirian GM, Stonecipher KG. Comparison of the IntraLase femtosecond laser and mechanical keratomes for laser in-situ keratomileusis. J Cataract Refract Surg. 2004;30(4):804-811.
9. Stahl JE, Durrie DS, Schwendeman FJ, et al. Anterior segment OCT analysis of thin IntraLase femtosecond flaps. J Refract Surg. 2007;23(6);555-558.
10.Steinert RF. Using IntraLase to improve penetrating keratoplasty. Refractive Eyecare. Feb 2007.
11.Price FW Jr, Price MO, Grandin JC, et al. Deep anterior lamellar keratoplasty with femtosecond-laser zigzag incisions. J Cataract Refract Surg. 2009;35(5):804-808.
© 2010 Abbott Medical Optics Inc. Advanced CustomVue, iFS, iLASIK and IntraLase are trademarks owned by or licensed to Abbott
Laboratories, its subsidiaries or affiliates. Accutane is a registered trademark of Hoffman-LaRoche Inc. AMADEUS is a trademark of
Surgical Instrument Systems. Cordarone is a registered trademark of Sanofi-Synthelabo, Inc. FEMTO LDV is a trademark of Ziemer Group.
2009.07.29-IL1180 Rev. A