DUBLIN, CA and JENA, GERMANY, August 22, 2006, /MARKET WIRE/
-- Carl Zeiss Meditec, Inc., one of the world's premier medical
technology companies, today announced the U.S. Food & Drug Administration
(FDA) has cleared the MEL 80™ Excimer Laser System for vision correction
eye surgery.
"The FDA clearance of the MEL 80 for myopic correction is a major
milestone achievement in our overall business strategy to provide
the most advanced refractive laser technologies worldwide," said
Ulrich Krauss, president and CEO, Carl Zeiss Meditec AG. "With more
than 750 excimer systems already delivered to customers around the
globe, CZM is well established in the market and the MEL 80 has
proven itself as one of the leading excimer laser systems. Access
to the U.S. market further strengthens our global refractive business."
Results from clinical studies found that 93 percent of patients
were corrected at three months to 20/20 or better visual acuity,
and 41 percent were corrected to 20/12.5 or better at six months.
Results also showed that 85 percent of patients achieved within
one-half of a diopter (optical power measurement) of the intended
correction at three months post-operative follow-up.
The MEL 80 Laser is designed to make the correction of vision defects
exceptionally effective and patient-friendly. The technology uses
a particularly small spot size and Gaussian beam profile, thereby
creating a corneal ablation which is even and is protective of the
surrounding tissue. The ablation process is also very fast, so there
is less dehydration of the eye. The thermally optimized distribution
of the laser firing pattern also protects the stroma, despite the
system's high ablation speed. Since the patient only needs to concentrate
on the fixation light for a few seconds, patient stress is considerably
reduced.
"The MEL 80 has superior characteristics that make it extremely
advanced," said Mark Packer, M.D., FACS, clinical associate professor,
Oregon Health and Science University, Portland, Ore., and a principle
investigator of the clinical trial. "Because of its speed, the amount
of time the cornea is exposed is reduced and the overall treatment
procedure is significantly shortened. Additionally, the laser is
able to preserve the natural curvature of the cornea ultimately
improving the quality of vision," continued Dr. Packer.
Preparations for commercial launch of the MEL 80 in the U.S. are
now being finalized. "Our overall strategic intent is to provide
not only the most advanced technologies, but also to offer innovative
systems solutions that best meet the needs and expectations of our
customers. We believe that the excellent results from the FDA clinical
studies will further improve the reputation of the MEL 80 as one
of the leading refractive laser systems worldwide," said Jim Taylor,
president and CEO of Carl Zeiss Meditec, Inc.
"In addition to the advanced excimer laser platform offered by our
MEL 80, we have also pursued the development of an advanced femtosecond
laser system for flap creation. The ongoing clinical testing of
these femtosecond technologies has been both more rapid and more
promising than we had anticipated, and a 510k has recently been
filed. As a result, our intent is to bring a truly unique and comprehensive
offering to our U.S. customers by integrating the launch of these
products."
