Jan 18, 2007 DUBLIN, CA MARKET WIRE -- Carl Zeiss Meditec, Inc. (CZM) reported that it has received
U.S. Food & Drug Administration (FDA) clearance to market the laser
keratome applications of its VISUMAX femtosecond laser system. The
company had previously projected that this clearance would be granted
in the second half of 2007, and the more rapid achievement of this
process is an important and welcomed milestone for the company.
The VISUMAX system is designed to provide smooth and precise
flap cutting capabilities for refractive laser surgery. This technology,
combined with CZM's MEL 80 excimer laser, delivers excellent clinical
outcomes coupled with the potential for a unique 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. Alternatively, either platform may be used separately
and/or in conjunction with other laser systems, but without the
full system integration benefits.
Both MEL 80 and VISUMAX technologies were recently displayed
and demonstrated at the American Academy of Ophthalmology (AAO)
in Las Vegas. The MEL 80 is an advanced refractive laser system
that has been marketed outside the U.S. since 2002. The MEL 80 recently
gained FDA clearance for sale in the U.S., and the related clinical
trials showed that 93 percent of patients were corrected to 20/20
or better visual acuity, with 41 percent achieving 20/12.5 or better
at six months. With the subsequent FDA clearance of the VISUMAX
femtosecond 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 Jim Taylor,
president and CEO of Carl Zeiss Meditec, Inc. "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 who expect and require the most advanced refractive
correction technologies and techniques."
"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
"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."