September
7, 2005
IRVINE, Calif.--(BUSINESS
WIRE)--Sept. 7, 2005-- Global Innovator in Femtosecond Laser Technology
Receives Industry's First 510K Clearance for Creating Corneal
Resections Performed in a Variety of Therapeutic Procedures.
IntraLase Corp. (NASDAQ:ILSE) today announced it has received
a new 510K clearance from the U.S. Food and Drug Administration
for use of the IntraLase FS30 femtosecond laser in creating the
corneal resections performed in lamellar keratoplasty and penetrating
keratoplasty procedures. The IntraLase FS30 laser is the first
and only laser to receive clearance for use in penetrating keratoplasty.
For the first time surgeons can use the power and precision of
the laser to complete resections in a wide variety of corneal
therapeutic applications. The new clearance allows use of the
IntraLase FS30 laser to create deep corneal incisions and the
full-thickness resections required for penetrating keratoplasty.
The Eye Bank Association of America estimates that more than 32,000
corneal transplant procedures were performed in the U.S. in 2004.
The new application of the IntraLase FS30 laser is the direct
result of the company's ongoing collaboration with the world's
leading corneal surgeons to develop innovative techniques with
and enhancements of the technology.
"This really opens up the door for additional uses of this
extremely versatile device," said Roger Steinert, M.D., professor
and vice chairman of the department of ophthalmology at the University
of California, Irvine, and president of the American Society of
Cataract and Refractive Surgeons. "In our initial clinical
work, we found that the laser has the ability to create shaped,
full-thickness corneal transplants that are much stronger than
traditional penetrating keratoplasty transplants with less induction
of astigmatism. In addition, transplants created with the laser
may require less suturing and faster visual rehabilitation.
"IntraLase is developing commercially available software
for these new applications as well as a new curved applanation
lens to facilitate deep corneal dissections. The laser's current
flat applanation lens provides the thin, planar flaps that have
recently been shown to improve LASIK outcomes.
"This technology may have additional applications in the
deep stroma, including Descemet's Stripping with Endothelial Keratoplasty
(DSEK) procedures," said Francis Price, M.D., of the Price
Vision Group in Indianapolis. "The laser's flat applanation
surface provides very uniform and smooth anterior resections.
But for deep stromal resections, a curved applanation provides
a smoother interface. In the future, IntraLase FS30 will utilize
both flat and curved applanation surfaces, providing the best
solution for any application."
The IntraLase FS laser was commercially introduced in late 2001
as the first laser available for creating corneal flaps. The IntraLase
laser is also cleared for anterior lamellar keratoplasty and intrastromal
ring implantation surgeries, which like LASIK benefit from customized
architecture and unsurpassed accuracy. As of June 30, 2005, 293
IntraLase FS lasers have been installed in refractive practices
worldwide and approximately 18 percent of LASIK procedures in
the U.S. used the IntraLase laser to create the corneal flap.
About IntraLase Corp.
IntraLase designs, develops, and manufactures an ultra-fast laser,
related software, and disposable devices used to create a corneal
flap, the first step in LASIK surgery for the correction of vision.
The company's products improve the safety, precision, and visual
results of LASIK procedures by providing a computer-controlled
laser solution in place of the hand-held mechanical, metal-bladed
microkeratome traditionally used to create corneal flaps. IntraLase
lasers are also used in surgical approaches to the treatment of
diseased corneas. The company's lasers and disposable per procedure
patient interfaces are presently marketed throughout the United
States and 21 other countries. IntraLase has headquarters and
manufactures its products in Irvine. For additional information,
visit the company's Web site: www.intralase.com.
Forward-Looking Statements
Statements contained in this press release that are not historical
information are forward-looking statements as defined within the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by the use of words such as "believe,"
"expect," "anticipate," "intend,"
"plan," "estimate," "project," or
words of similar meaning, or future or conditional verbs such
as "will," "would," "should," "could,"
or "may." Such forward-looking statements are subject
to risks and uncertainties that could cause actual results to
differ materially from those projected or implied. Those risks
and uncertainties include, but are not limited to: the degree
of continued acceptance of LASIK surgery; potential complications
revealed by long-term follow up; the extent of adoption of our
product offering by LASIK surgeons; general economic conditions;
changes in federal tax laws governing the ability of potential
LASIK patients to use pre-tax dollars to pay for LASIK surgery;
the scope of government regulation applicable to our products;
patients' willingness to pay for LASIK surgery; our ability to
compete against our competitors; the effectiveness of our measures
to ensure full payment of procedure fees; the occurrence and outcome
of product liability suits against us; our ability to adequately
protect our intellectual property; whether we become subject to
claims of infringement or misappropriation of the intellectual
property rights of others; the continued availability of supplies
from single-source suppliers and manufacturers of our key laser
components; the ability of our managers, operations, and facilities
to manage our growth; the success of our expansion into markets
outside the United States; whether we lose any of our key executives
or fail to attract qualified personnel; or if our new products
or applications fail to become commercially viable.
Certain of these risks and uncertainties, in addition to other
risks, are more fully described in the company's quarterly report
on form 10-Q for the period ending June 30, 2005, as filed with
the Securities and Exchange Commission on Aug. 10, 2005.
These forward-looking statements are made only as of the date
of this press release, and the company assumes no obligation to
update or revise the forward-looking statements, whether as a
result of new information, future events, or otherwise.
CONTACT:
For further information call Sigmacon Medical Products, 1-800-898-7455
SOURCE: IntraLase Corp.
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