KS-AquaPORT™ Pre-Launch Utilizing the Proprietary CentraFLOW™ Technology Begins
Eliminates a Step in the ICL Procedure Making it
More Efficient and Cost Effective
Successful Visian ICL Implants Worldwide Now Surpass 225,000
Calif., June 27,2011 /PRNewswire/ -- STAAR Surgical Company (NASDAQ: STAA), the leading developer,
manufacturer and marketer of minimally invasive refractive lenses that go
inside the eye, today announced the completion of the first procedures to
implant its recently CE Mark-approved Visian® Implantable Collamer® Lens (ICL™)
V4c design. Dr. Erik Mertens, Medical Director and founder of the Medipolis
Eye Centre in Antwerp, Belgium, implanted the Visian ICL V4c model in five eyes
with myopia ranging from -6.0 to -8.0 diopters on Friday, June 24th.
These are the first procedures under the Company's pre-launch plan for
the product in eight sites and 100 eyes before the full market launch in the
countries that accept CE Mark approvals.
Visian V4c design incorporates the KS-AquaPORT™, or KS-AP™, in the center of
the ICL optic, to optimize the flow of fluid within the eye. The KS-AP is
named after Dr. Kimiya Shimizu who helped pioneer the technology. The
CentraFLOW™ proprietary technology eliminates the need for the surgeon to
perform a YAG peripheral iridotomy procedure days before the ICL implant, which
leads to more comfort for the patient and a more convenient, efficient ICL
experience for both the patient and the surgeon. The Company received CE
Mark approval for this new ICL technology in April, 2011.
surgeries in Belgium are a very important first step in the execution of our
plan to launch the latest Visian ICL design in Europe," said Hans
Blickensdoerfer, STAAR's President of Europe and Latin America. "Dr.
Mertens is a leading refractive surgeon globally recognized for his work in
refractive surgery. His experience and continued endorsement of the
Visian technology will help us as we expand the market for this product
V4c design offers significant benefits," commented Dr. Mertens.
"Since the approval late last year of the expanded range ICL, I have
implanted the ICL in patients with as low as -1.5 diopters of myopia. Based on
this initial experience, the new V4c design has proven to be more comfortable
and convenient for the patient, as well as for me and my staff.
Eliminating the iridotomy step puts the ICL procedure on the same level
of efficiency as LASIK and it provides as good, if not better, visual results
for the patient. There has been no increase in intraocular pressure and the
patients are experiencing the same excellent visual results. This latest ICL
development eliminates a step in the procedure, and I believe this
revolutionary CentraFLOW™ technology will be a game changer for implant-based
Company received CE Mark approval on the Visian ICL V4c for the -0.5 diopter to
-18.0 diopters myopic range and +0.5 cylinder power to +6.0 for the Toric ICL
models. The comprehensive clinical research conducted by Dr. Kimiya
Shimizu, Professor and Chair of the Department of Ophthalmology at Kitasato
University in Sagamihara, Japan, demonstrated the benefits of the new V4c
design and was very important to the Company's success in receiving regulatory
studied the KS-AquaPORT Visian ICL in two clinical trials during 2008 and
2010," said Dr. Shimizu. "These trials were contralateral, meaning
that we implanted the ICL with the KSAP in one eye without performing an
iridotomy, and we implanted the ICL without the technology in the other eye
where iridotomies were performed. The KS-AP technology was aberration
free and all visual results were excellent and identical in both the KS-AP and
the conventional ICL. The most impressive outcome was the intraocular pressure
post-operatively. It was identical and normal in both sets of eyes.
Maintaining the natural flow of aqueous within the eye bathes the crystalline
lens with nutrients and could serve to further minimize the risk of cataract
formation. We have continued to use the technology in our patients since the
trials and they are very happy."
again we would like to express our sincere appreciation to Dr. Shimizu for his
ongoing pioneering contributions to the enhancements of the ICL technology as
well as to the eight surgeons participating in the pre-launch surgical
procedures," said STAAR Surgical CEO Barry G. Caldwell. "The
port in the ICL is named after Dr. Kimiya Shimizu for his efforts in advancing
this technology. The CentraFLOW technology featuring the KS-AP further
differentiates our ICL technology with benefits to both patient and surgeon.
They are a testament to STAAR's continued research and development
capabilities, which have produced five new product approvals planned for market
launches during the second half of this year. The Company continues to
make excellent progress toward increasing consumer awareness of the Visian ICL
and expanding global market share. There now have been over 225,000
successfully completed ICL implants throughout the world."
which has been dedicated solely to ophthalmic surgery for over 25 years,
designs, develops, manufactures and markets implantable lenses for the eye.
All of these lenses are foldable, which permits the surgeon to insert
them through a small incision. A lens used to replace the natural lens
after cataract surgery is called an intraocular lens or "IOL."
A lens used in refractive surgery as an alternative to LASIK is called an
Implantable Collamer Lens or "ICL." Over 225,000 Visian ICLs
have been implanted to date; to learn more about the ICL go to: www.visianinfo.com. STAAR has approximately
300 full time employees and markets lenses in approximately 50 countries.
Headquartered in Monrovia, CA, it manufactures in the following
locations: Nidau, Switzerland; Ichikawa City, Japan; Aliso Viejo, CA; and
Monrovia, CA. For more information, please visit the Company's website at