Carl Zeiss Meditec: New technology for correction of vision receivesmarket clearance in the USA

16:40 22.01.07

(Jena, January 22, 2007) Carl Zeiss Meditec AG received U.S. Food &
Drug Administration (FDA) clearance to market the laser keratome
applications of its' VisuMax femtosecond laser system. The completion
of the approval process is an important and welcome milestone for the
company.
The VisuMax system is designed to provide smooth and precise flap
cutting capabilities for refractive laser surgery. Until now, this
cutting was accomplished mechanically using a blade (microkeratome),
and then an excimer laser produced the previously calculated optimum
form of the cornea.
The new technology delivers - separately or in combination with Carl
Zeiss Meditec's MEL 80 excimer laser - excellent clinical outcomes
coupled with the potential for an optimized work flow for refractive
surgeons and improved comfort for their patients. Using a unique
pivoting patient bed and an integrated data management system, the
refractive surgeon will be able to complete a full refractive
procedure without the need to move the patient or to perform
redundant data entries.
Both MEL 80 and VisuMax technologies were recently displayed and
demonstrated at the American Academy of Ophthalmology (AAO) in Las
Vegas. The MEL 80 recently gained FDA clearance for sale in the US,
and the related clinical trials confirmed the extraordinary capacity
of the system and showed that 93% of patients were corrected to 20/20
or better visual acuity, with 41% achieving 20/12.5 or better at six
months. With the subsequent FDA clearance of the VisuMax femtosecond
laser platform, the company is now positioned to more fully exploit
the technology advantages and clinical benefits of its full
refractive laser portfolio. A commercial launch of the femtosecond
technology is planned for mid-2007. In the interim, the company will
continue ongoing clinical evaluations for the recently approved laser
keratome applications. The company has also recently demonstrated
the unique potential of the VisuMax technology to perform a complete
"all in one" refractive correction procedure, and clinical testing
will be continued for that application as well.
"We believe that the field of refractive laser surgery offers
significant opportunity for the type of technology innovation that
Zeiss has pursued throughout our 160 year history," said Ulrich
Krauss, President and CEO of Carl Zeiss Meditec AG. "Since our
initial disclosure of the clinical progress of our femtosecond
system, we have been gratified by the enthusiastic encouragement and
support that we have received from experienced refractive surgeons
around the world. They recognize the inherent potentials in these
advances along with the significant benefits that will emerge for
patients and for clinicians."
"The apparent advantages of the VisuMax system are not limited to
those normally recognized for a femtosecond laser flap cut" stated
Walter Sekundo, MD, of the University of Mainz, Germany. "Due to the
special design of the contact glass and the low IOP increase, the
perfusion of the central retinal artery has not been impaired, and
our patients were able to see the fixation light throughout the
procedure. Moreover, the VisuMax provides a new level of cutting
accuracy for corneal incisions, as evidenced by the results of our
successful demonstration of the so-called Femtosecond Lenticule
Extraction procedures."
"In my opinion," Sekundo continued, "these features contributed
significantly to our excellent visual acuity results of up to 20/10
one day post-op, and we saw no incidence of transient light
sensitivity syndrome (TLSS) or DLK in any of the study group
patients."
The MEL 80 and the VisuMax systems will be available for
demonstration at the American Academy of Refractive and Cataract
Surgery (ASCRS) in San Diego, California April 27 - May 1, 2007 and
at the upcoming European Society of Refractive and Cataract Surgery
(ESCRS) in Stockholm, Sweden September 8-12, 2007.
 
Brief profile
Built on an unparalleled 160-year heritage of optical innovation,
Carl Zeiss Meditec AG (International Securities Identification Number
DE000531370) is one of the world's leading eye care solutions
providers.
Its product line includes systems for the diagnosis and treatment of
the four main diseases of the eye: vision defects (refraction),
cataracts, glaucoma and retinal disorders. The company has
incorporated its technological expertise into a stream of product
innovations throughout the years, from slit lamps and fundus cameras;
to the Humphrey® Field Analyzer, recognized as the global standard
for glaucoma detection and management; to its newest applications of
lasers as embodied in its leading-edge MEL 80(TM) refractive laser
and innovative Stratus OCT(TM) device for glaucoma diagnosis. Since
2005, the company has also been present in the market for intraocular
lenses and consumables, and now covers almost the entire value chain
of ophthalmic surgery. The company plans to continue its profitable
growth in the future. The acquisition of Carl Zeiss Surgical further
supplements the product portfolio in ophthalmic surgery and opens up
additional growth prospects in neuro and ear, nose and throat
surgery. Carl Zeiss Surgical is the world's leading provider of
visualization solutions in these two areas.
Carl Zeiss Meditec AG is based in Jena, Germany, with subsidiaries in
Pirmasens, Germany (Carl Zeiss Surgical GmbH, Carl Zeiss Meditec
Systems GmbH), the USA (Carl Zeiss Meditec Inc.), Japan (Carl Zeiss
Meditec Co., Ltd.), Spain (Carl Zeiss Meditec Iberia S.A.) and France
(Ioltech S.A., Carl Zeiss Meditec France SAS). The rapidly aging
global population and other trends are expected to grow the
ophthalmic market in the long term. The company is focused on
applying innovative optical technologies to protect and enhance
vision now and into the future.
Thirty-five percent of Carl Zeiss Meditec shares are in free float.
The remaining 65 percent are held by Carl Zeiss, one of the world's
leading international groups engaged in the optical and
opto-electronics industry.
Contact
Kerstin Nössig / Public Relations
Goeschwitzer Straße 51-52
07745 Jena, Germany
Telefon: +49 (0) 36 41 - 2 20 - 3 35
Telefax: +49 (0) 36 41 - 2 20 - 2 82
E-Mail: k.noessig@meditec.zeiss.com
Web: http://www.meditec.zeiss.com
 
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