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news Topics Issue 2 / 2007 Market launch for the SCHWIND AMARIS 1-2 Multi-center LASIK study: Excellent results with the SCHWIND AMARIS 2-3 Innovation offensive: Research & Development achieved technological quantum leaps 4-5 The others must measure against it: Reference doctors rate the SCHWIND AMARIS 6-8 Market launch for the SCHWIND AMARIS TotalTech Laser introduced for the first time at the ESCRS 2007 Faster, stronger, more precise: At the ESCRS Congress (European Society of Cataract and Refractive Surgeons) in Stockholm, SCHWIND eye-tech- solutions presents a new excimer laser generation, redefining perfection in refractive corneal surgery. ”With the SCHWIND AMARIS, we have developed an all-rounder with unmatched high performance, thereby offering an extra- ordinarily high level of accuracy and the first and only laser to combine all available state-of-the-art technologies in one system“, says CEO Rolf Schwind. The ”TotalTech Laser“ impresses through a true pulse frequency of 500 Hz and, with two automatically adapted fluence values, ensures perfect ablation control. Depending on the refraction to be corrected, approxi- mately 80 percent of the corneal ablation is performed with a high fluence level, thus speeding up the treatment. Fine correction takes place with a low fluence level, improving the resolution. With this intelligent process, the laser treatment is signifi- cantly shortened, especially when higher refractions are corrected, and at the same time carried out with exceptional precision. The correction of one diopter takes on average less than 2.5 seconds with the SCHWIND AMARIS. Thereby, the stroma is pre- served through thermally optimized laser pulse distribution. SCHWIND AMARIS – unmatched high performance Two automatically adapted fluence values

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Page 1: Deka-bAV Fonds HJB0607 - eye-tech-solutions.com page6of8 Issue2/2007 After performing more than 37,000 excimerlaserrefractivesurgerieswith differentexcimerlasers,includingthe latest

news

Topics Issue 2/ 2007

Market launch for the SCHWIND AMARIS 1-2

Multi-center LASIK study: Excellent results with the SCHWIND AMARIS 2-3

Innovation offensive: Research & Development achieved technological quantum leaps 4-5

The others must measure against it: Reference doctors rate the SCHWIND AMARIS 6-8

Market launch for the SCHWIND AMARISTotalTech Laser introduced for the first time at the ESCRS 2007

Faster, stronger, more precise: At

the ESCRS Congress (European Society

of Cataract and Refractive Surgeons)

in Stockholm, SCHWIND eye-tech-

solutions presents a new excimer laser

generation, redefining perfection in

refractive corneal surgery. ”With the

SCHWIND AMARIS, we have developed

an all-rounder with unmatched high

performance, thereby offering an extra-

ordinarily high level of accuracy and

the first and only laser to combine all

available state-of-the-art technologies

in one system“, says CEO Rolf Schwind.

The ”TotalTech Laser“ impresses

through a true pulse frequency of

500 Hz and, with two automatically

adapted fluence values, ensures

perfect ablation control. Depending on

the refraction to be corrected, approxi-

mately 80 percent of the corneal

ablation is performed with a high

fluence level, thus speeding up the

treatment. Fine correction takes place

with a low fluence level, improving

the resolution. With this intelligent

process, the laser treatment is signifi-

cantly shortened, especially when

higher refractions are corrected, and

at the same time carried out with

exceptional precision. The correction

of one diopter takes on average less

than 2.5 seconds with the SCHWIND

AMARIS. Thereby, the stroma is pre-

served through thermally optimized

laser pulse distribution.

SCHWIND AMARIS – unmatched high performance

Two automatically adapted fluence values

Page 2: Deka-bAV Fonds HJB0607 - eye-tech-solutions.com page6of8 Issue2/2007 After performing more than 37,000 excimerlaserrefractivesurgerieswith differentexcimerlasers,includingthe latest

news

page 2 of 8 Issue 2/2007

Five-dimensional eyetracking

1050 Hz turbo eyetracker

An eyetracker must work at a signifi-

cantly higher frequency than the laser

in order to safely allow a very short

ablation time. The SCHWIND AMARIS’

1050 Hz turbo eyetracker, with a

response time of less than three milli-

seconds, serves to provide unsur-

passed precision in the positioning

of each laser pulse. The extreme speed

and other groundbreaking features,

Innovative particle aspiration system

such as rotation balance, limbus

tracking and static as well as dynamic

cyclotorsion control, ensure exact

compensation of every eye movement,

on into the fifth dimension.

Safe and comfortable

The Treatment Assistant Manager

software module, especially devel-

oped for the SCHWIND AMARIS, guides

through the treatment safely and

comfortably. Each treatment step is

defined: The default settings are set

at levels that are practical for the

surgeon, but can also be changed

or expanded and saved. With the

particle aspiration system, developed

on the basis of comprehensive flow

analysis, energy-reducing particles are

efficiently removed during ablation.

This concept of maximum safety is

completed through the integration of

high-resolution online pachymetry.

Unique ergonomic advantages that

optimize the treatment process are

also included. The laser arm and

the patient bed, for example, can be

swiveled 90°. This makes patient pre-

paration and the combination with

other medical devices easy and com-

fortable. The treatment monitor is

adjustable in any direction – assisting

personnel can work with it comfortably

too.

Excellent results already after only one monthThe first international multi-center LASIK study with the SCHWIND AMARISExcellent visual acuity, extremely high

predictability and low variance in

results: These were substantiated in

one-month results of a recent multi-

center LASIK study in which the new

excimer laser generation SCHWIND

AMARIS was employed for the first

time. The study was carried out on

389 eyes by SCHWIND reference sur-

geons Maria-Clara Arbelaez, MD,

Oman, Ioannis Aslanides, MD, Greece,

Francesco Carones, MD, Italy, Tobias

Neuhann, MD, Germany, as well as

Alena Feuermannova, MD and Pavel

Rozsival, MD, Czech Republic. Treated

patients were myopes, either pure

or with astigmatism, between 18 and

60 years of age. The preoperative

spherical equivalent (SEQ) ranged

from -0.50 D to -8.25 D, and astig-

matism was treated up to -5.00 D.

All patients were corrected with

SCHWIND’s „Aberration-Free“ treat-

ment.

Page 3: Deka-bAV Fonds HJB0607 - eye-tech-solutions.com page6of8 Issue2/2007 After performing more than 37,000 excimerlaserrefractivesurgerieswith differentexcimerlasers,includingthe latest

Issue 2/2007 page 3 of 8

Postoperatively, an average SEQ of

- 0.16 with a very low standard

deviation of 0.25 D was observed. In

74 percent of all treated eyes, the

planned refractive result was achieved

within a minimum deviation of ± 0,25

already after one month. 93 percent

were in the range of ± 0.50 D and

100 percent of eyes within ±1.00 D

(see figure 1). High postoperative

stability was already observed after

one week. This very rapid convergence

toward the planned refractive result

implies that the recovery time after

surgery with the SCHWIND AMARIS

is very short.

Again after only one month, more

than 92 percent of treated patients

attained post-operative uncorrected

visual acuity (UCVA) of 20/20 or better.

No single patient eye realized a

visual acuity of less than 20/32. In 99

percent, an UCVA of 20/25 or better

was achieved. More than 32 percent

of study participants even achieved

visual acuity of 20/16 or better (see

figure 2).

Altogether, only very slight scattering

of results was observed and no trend

toward over- or undercorrections

was detected after only one month.

All results were obtained without the

use of individual nomograms.

summed up Dr. Maria-Clara Arbelaez,

Oman, at the presentation of the

multi-center study on the occasion of

the ESCRS 2007 in Stockholm.

„In my opinion, the extraordinary

performance of the SCHWIND AMARIS

decisively contributed to the excellent

clinical results that we have seen so far“,

+- 0,25

+- 0,5

+- 1,0

+- 2,0

Page 4: Deka-bAV Fonds HJB0607 - eye-tech-solutions.com page6of8 Issue2/2007 After performing more than 37,000 excimerlaserrefractivesurgerieswith differentexcimerlasers,includingthe latest

news

page 4 of 8 Issue 2/2007

Innovation offensive with the SCHWIND AMARISResearch & Development achieved technological quantum leaps

developed eye model translates linear

detected movements into horizontal

and vertical rotations. Innovation is

also demonstrated by the unique

particle aspiration system, whose

concept is based on comprehensive

flow analysis by SCHWIND. Energy-

reducing particles are efficiently

removed during ablation. In order

to minimize energy losses, the

engineers furthermore developed a

completely enclosed beam path under

vacuum.

From the left: Thomas Klinner, and Thomas Hollerbach, Research & Development department,working on development of the eyetracker camera

The new excimer laser generation,

SCHWIND AMARIS, impresses with a

multitude of groundbreaking inno-

vations. From the very beginning, the

development activities for this ambi-

tious project concentrated on setting

new outstanding technological and

clinical standards in refractive surgery.

SCHWIND engineers with different

specializations, mathematicians and

physicists worked towards a single

goal: To realize the maximum of

today’s technological possibilities and

to integrate the experience gained

through the up to now successful

laser generations from SCHWIND.

The development process started

with a strategic idea management – in

close partnership with internationally

renowned refractive surgeons. Here,

SCHWIND experts acted as ´Trend

Scouts´. “We explored and achieved

long-term sustainable, technological

quantum leaps“, says Thomas Holler-

bach, Head of Research & Develop-

ment department. This included an

comprehensive risk analysis and the

development of sustainable solutions.

The outcome was, for instance, a

unique technique, that safely allows

the realization of significantly shorter

treatment time. Two automatically

adapted fluence values ensure per-

fect ablation control. Depending on

the planned refractive correction,

approximately 80 percent of the cor-

neal ablation is realized with a high

fluence level in order to accelerate

the treatment. The fine correction

takes place with a low fluence level.

Rotation balance

Another groundbreaking development

is the rotation balance in the 5-D

Eyetracker, through which so-called

„eye rolling“ is for the first time

compensated. Therewith, a SCHWIND-

Page 5: Deka-bAV Fonds HJB0607 - eye-tech-solutions.com page6of8 Issue2/2007 After performing more than 37,000 excimerlaserrefractivesurgerieswith differentexcimerlasers,includingthe latest

Issue 2/2007 page 5 of 8

High stability

SCHWIND has redefined perfection in

every detail: The SCHWIND AMARIS’

high-end microscope, developed

especially for use with excimer lasers

and with a 14° stereopsis, suits

natural, threedimensional vision and

delivers very good contrast, true

color brilliance and a superior depth

of focus. High flexibility also ranks

among the core characteristics of

the all-rounder. Both the laser arm

and the patient bed can be swiveled

independently.

The entire construction was carried

out three-dimensionally in order to

allow the performance of optimal soft-

ware-supported material and load

analysis from the very beginning. This

ensured – already in the planning

phase – extremely high mechanical

stability of the laser. A team of 20

experts ensured the ideal union of

unequaled cutting edge technology,

ergonomic design and, oriented toward

a requirement of everyday treatment

standards, high user-friendliness. The

complete conception and development

of control and application software

took place in-house. Smaller tasks

such as, for example, the layout deve-

lopment of circuit boards, were out-

sourced to competent external part-

ners. SCHWIND AMARIS’ main control

processor runs on the basis of Debian-

Linux – an operating system that is

also employed in aviation due to its

high stability.

Low service costs

Another requirement in construction

and hardware has been to make it

easy to maintain as well. The laser

control system was modularly built

and is distributed among several con-

trol units. Correspondingly, upgrades

are easy to perform: They require

only on a small scale exchange or

modification of parts. The laser head

can be swiveled and must not be

removed for maintenance. Such well

thought-out concepts keep the amount

of work and service costs low. An

important part of the development

process is made up of validation and

documentation. Thanks to rapid and

successful integration, the laser could

be brought into series production

within only a short time. The result:

The SCHWIND AMARIS carries the

European CE-mark, as well as the

certification of other international

safety standards and can therefore

be immediately used virtually word-

wide.

Thomas Bader, Research & Development, constructs a flow analysis for the particleaspiration system

Swivelinglaser arm

Page 6: Deka-bAV Fonds HJB0607 - eye-tech-solutions.com page6of8 Issue2/2007 After performing more than 37,000 excimerlaserrefractivesurgerieswith differentexcimerlasers,includingthe latest

news

page 6 of 8 Issue 2/2007

After performing more than 37,000

excimer laser refractive surgeries with

different excimer lasers, including the

latest 10.000 cases done with the

SCHWIND ESIRIS, which gave me the

answer to treat simple and very com-

plex cases using the SCHWIND-CAM

platform, such as ”Aberration-Free”

based treatments, ocular wavefront

based treatments and corneal wave-

front based treatments with excellent

results: I was recently able to perform

550 consecutive cases with the new

generation SCHWIND AMARIS excimer

laser and would like to say what this

name means to me:

Intelligent – There are built-in fea-

tures that make this machine very

smart and user friendly, with software

that guides you step by step. There is

a high resolution stereoscopic micro-

scope, slit focusing illumination,

integrated online pachymetry (OCP)

and a slit lamp.

Safe – The knowledge, the experience

and the results obtained previously

with the SCHWIND-CAM software, are

used and built into the SCHWIND

AMARIS profiles. This means minimal

need for nomograms and no surprises

with the results.

My results with the SCHWIND AMARIS

are amazing so far! More than

amazing! Previously, our re-treatment

rate was 2%. With the new system, we

can already see with the early results,

that it is far lower.

Contact: Maria Clara Arbelaez, MDMedical DirectorMuscat Eye Laser CenterMuscat, Oman – Phone +968 24691414Email: [email protected]

The others must measure against itReference doctors rate the SCHWIND AMARIS

Advanced – The SCHWIND AMARIS

is a super fast excimer laser with a

0.54 mm SuperGaussian profile at true

500 Hz repetition rate and automatic

fluence adjustment (high and low

fluence levels accordingly with the

planned correction), with a 1050 Hz

turbo eyetracker considering static

and dynamic cyclotorsion (5D) and

detection of both iris and limbus.

Multifunctional – On the same system

I have the possibility to perform

”Aberration-Free” treatments, ocular

wavefront treatments, corneal wave-

front treatments and pachymetry-

assisted lamellar corneal surgeries.

Anatomic design that makes it very

easy to use and handle, all controls

are well placed and easy to reach

and manipulate. The laser arm can

be swiveled 90°, giving space for the

patient and for other instruments in

the operating room.

Reliable – The particle aspiration

system gives a totally stable climate

around the eye that makes the system

fully independent from the environ-

mental conditions and air flow.

Maria Clara Arbelaez, MD

Page 7: Deka-bAV Fonds HJB0607 - eye-tech-solutions.com page6of8 Issue2/2007 After performing more than 37,000 excimerlaserrefractivesurgerieswith differentexcimerlasers,includingthe latest

Issue 2/2007 page 7 of 8

I had the opportunity to use five different

laser platforms in my career. SCHWIND

AMARIS opens up a new dimension in

safety and quality and fulfills highest

expectations both in patient care and

clinical demands – redefining, what

state-of-the-art in contemporary re-

fractive surgery is. We now have a

laser platform of a totally new genera-

tion available, that includes unparal-

leled, highly sophisticated technology

both on theoretical and practical level.

You work with a 500 Hz repetition rate

and a 1050 Hz Eyetracker, which is the

absolute theoretical and safe match

regarding a state of the art machine.

This makes this system not only safe

but as well significantly shortens treat-

ment time precluding most potential

problems – especially in high ametro-

pias - where every single detail plays a

major role for the final outcome. Due

to the laser beam profile a very smooth

ablation is achieved, which leads to a

very quick healing in surface treat-

ments. The SCHWIND AMARIS combi-

nes high speed with relatively less

energy compared to competitor laser

systems. That makes the system safe

and effective. It’s definitely a new era:

The system has taken care of tracking

and cyclotorsion problems and it

moved all safety features to a higher

quality stage. The SCHWIND AMARIS

addresses the needs of high-volume sur-

geons and of medium-volume surgeons

as well: It optimizes the workflow and

it’s easy to follow - you are guided

through the process and therefore also

not very experienced surgeons will find

it easy to use. SCHWIND AMARIS, apart

from being an excellent primary treat-

ment platform, due to its unique charac-

teristics in combination with the highly

precise corneal wavefront analysis is

also an invaluable retreatment tool and

completes a comprehensive package

for any competitive refractive surgeon.

Contact: Ioannis M Aslanides, MDAssistant Clinical ProfessorWeill Cornell Medical College, New YorkMedical Director Emmetropia Mediterranean EyeInstitute,Crete,Greece – Phone +302810226198Email: [email protected]

I had the opportunity to use seven

different laser systems. I like the

SCHWIND AMARIS, in particular, be-

cause it gives the refractive surgeon

full flexibility regarding the potential

for treatments, whether they be

aberration-free, topography-guided or

wavefront-guided custom ablations.

From my point of view, the extreme

reliability in the interaction of ablation

speed and eyetracker is the most

interesting feature for the surgeon.

For the patients the most obvious

appealing point is that they only have

to stay under the laser for a few

seconds. The minimized treatment

time does not cause any kind of

anxiety because there is not enough

time to develop any kind of worry. That

is the case for high refractions as

well as for low refractions. For lower

corrections, it takes only 3 or 4

seconds; for higher corrections it

takes about 20 seconds – not time

enough for getting them worried.

Although the clinical results with

the SCHWIND AMARIS are still pre-

liminary, I’m impressed by the imme-

diate postoperative “day one” results:

The vast majority of my patients had

a best corrected visual acuity of 20/20

or better. From this we can draw the

conclusion that the recovery time with

the SCHWIND AMARIS is very short.

Furthermore, I like very much the

ergonomics of the new laser. The

positioning of the surgeon is very

Ioannis M Aslanides, MD

Francesco Carones, MD

Page 8: Deka-bAV Fonds HJB0607 - eye-tech-solutions.com page6of8 Issue2/2007 After performing more than 37,000 excimerlaserrefractivesurgerieswith differentexcimerlasers,includingthe latest

page 8 of 8 Issue 2/2007

ImprintSCHWIND eye-tech-solutions GmbH & Co. KG · Mainparkstrasse 6-10 · D-63801 Kleinostheim · www.eye-tech-solutions.comEditor: Antje Splittdorf · fon: +49 (0) 60 27 – 5 08-164 · email: [email protected]

good. With other laser systems you are

close to the laser, but many controls

are pretty much far away from your

sitting position. Not with the SCHWIND

AMARIS. You work in a convenient

position almost like in a comfortable

driver seat in a car – all your operatio-

nal controls are very easy to reach

and clearly arranged.

The swiveling laser arm provides

several advantages such as comfor-

table patient preparation. The storing

of the laser arm in the parking position

gives smaller eye clinics the oppor-

tunity to use the space for other

purposes. Moreover, you can use the

same operating room and position for

performing a cataract surgery.

Contact: Francesco Carones, MDMedical DirectorCarones Ophthalmology CenterMilan, Italy – Phone +3902 76318174Email: [email protected]

My general impression: The SCHWIND

AMARIS is an excellent all-rounder as

well as comfortable for both doctor

and patient. I am very content with the

speed of ablation, because sometimes

the patients are not able to fixate on

the light for long time. The results are

so far more than satisfactory. One day

after surgery, all my LASIK-patients

attained a best corrected visual acuity

of 20/20 and 20/16. In the majority of

the patients the uncorrected visual

acuity was the same. It was seen that

the laser facilitates extremely smooth

treatment surfaces, which might con-

tribute to a better postoperative healing

process. The SCHWIND AMARIS is very

userfriendly and optimizes the refrac-

tive surgeon’s workflow. In conclusion,

the fact that I treated my own son with

the SCHWIND AMARIS, seems to be the

most convincing proof that I complete-

ly trust in the all encompassing capa-

bilities of this new laser generation.

Contact: Alena Feuermannova, MDCharles UniversityHradec Kralove, CZ – Phone + 420 49 583 -3336Email: [email protected]

SCHWIND AMARIS fulfills in nearly all

cases the long list of desires and

necessities that have become evident

over the past 15 years. Until now,

the unique combination of all con-

veniences such as iris detection, online

pachymetry, fast eyetracking, super-

fast tissue-saving ablation, diagnostic

slitlamp and swiveling patient bed

was not be found on the market.

Other very interesting and important

integrated innovations, too numerous

to all be listed here, can be discovered

and enjoyed by the SCHWIND AMARIS

user.

A learning phase must be calculated

into the initial process, but it is

short and pleasant. Reasons for the

necessity of every technical innovation

are, besides the significantly improved

safety for patients, the quality, speed

and sustainability of the treatment.

The SCHWIND AMARIS has succeeded

in setting a new standard that other

manufacturers have to measure

against.

Contact: Tobias Neuhann, MDMedical DirectorAaM Augenklinik am MarienplatzMunich, Germany – Phone +89 72 32 41 080Email: [email protected]

Alena Feuermannova, MD

Tobias Neuhann, MD