BUSINESS WIRE
SANTA CLARA, Calif.--(
BUSINESS WIRE)--Global ophthalmic company
OptiMedica
Corp. has announced the U.S. Food and Drug Administration (FDA)
510(k) market clearance of its
Catalys
Precision Laser System, a next generation laser cataract surgery
system that brings unequaled precision and accuracy and a markedly
streamlined workflow to the laser cataract procedure. Catalys combines a
femtosecond laser, integrated Optical Coherence Tomography (OCT) imaging
and OptiMedica’s breakthrough pattern scanning technology in an
ergonomic, easy-to-use system that allows cataract surgeons to perform
image-guided pre-operative laser lens conditioning. The system is FDA
cleared for capsulotomy (a circular incision in the lens capsule) and/or
lens fragmentation (segmenting and softening of the lens to prepare for
removal).
“The FDA approval of Catalys is an exciting development in the emerging
field of laser cataract surgery and a key milestone in the history of
OptiMedica,” said Mark J. Forchette, OptiMedica president and chief
executive officer. “OptiMedica has been committed to defining and
delivering the standard for precision and accuracy in laser cataract
surgery since the day our company was founded. We are proud to introduce
the industry’s most sophisticated laser cataract surgery system to U.S.
patients and physicians. I want to commend our team on this important
achievement.”
Catalys is the product of an extensive effort by OptiMedica to deliver
the precision and safety benefits of femtosecond laser to cataract
surgery, a widely performed procedure estimated at 19 million cases
worldwide per year.1 One of the most important steps during
laser cataract surgery is creating the capsulotomy, as its size, shape,
and positioning may be key determinants for effective lens position.2
In fact, a deviation of just 0.5 mm from the intended effective lens
position has been shown to result in 1.00 diopters of refractive error.3
Clinical study results published in the peer-reviewed Journal
of Cataract & Refractive Surgery have demonstrated that Catalys
delivers unequaled precision and accuracy, producing capsulotomies that
are within 30 microns of intended size and 80 microns of intended
center, with near perfect circularity.4 Laser lens
fragmentation with Catalys has also been shown to greatly improve the
ease of lens disassembly, reducing cumulative dissipated energy (CDE)
during ultrasound phacoemulsification by approximately 40 percent.5
“The product of years of development and refinement, Catalys is a
sophisticated yet simple-to-use device that delivers unequaled precision
and is, quite frankly, the most well designed medical product I have
ever seen,” said William J. Culbertson, M.D., Professor of
Ophthalmology, The Lou Higgins Distinguished Chair in Ophthalmology,
Bascom Palmer Eye Institute, Miller School of Medicine, University of
Miami. “My colleagues and I have been fortunate to have access to the
Catalys technology for years, and we firmly believe it will
revolutionize cataract surgery.”
OptiMedica developed the Catalys system in close collaboration with a Medical
Advisory Board of cataract experts from around the world, with the
shared objective to deliver unprecedented accuracy, an exceptional
experience and a seamless fit into surgical center workflow. Key
innovations reflecting this objective include a Liquid
Optics™ Interface that ensures stable system-patient attachment and
optimizes the optical path to the patient’s eye, and a proprietary Integral
Guidance™ system that ensures the femtosecond laser pulses are
delivered safely and precisely to the intended location. In addition,
the system features an easy-to-use and elegant graphical user interface
designed to simplify the planning process and minimize the time the
patient is under the dock.
Catalys was CE mark approved in August 2011 and has since been shipped
to leading ophthalmic centers outside the United States.
About OptiMedica
Founded in 2004 and headquartered in Santa Clara, Calif., OptiMedica
Corp. is a Silicon Valley-based global ophthalmic device company
dedicated to developing performance-driven technologies that improve
patient outcomes. Exclusively focused in the cataract therapeutic area,
the company has developed the Catalys Precision Laser System to deliver
unparalleled precision in cataract surgery through image-guided
pre-operative lens conditioning. Catalys is U.S. Food and Drug
Administration 510(k) cleared for market and CE mark approved for
performing capsulotomy and/or lens fragmentation during cataract
procedures.
OptiMedica’s legacy of innovation in ophthalmology also includes the
development and commercialization of the PASCAL® Method of retinal
photocoagulation, which was acquired by Topcon Corp. in August 2010. The
company is funded by Kleiner Perkins Caufield & Byers, Alloy Ventures,
DAG Ventures, BlackRock Private Equity Partners and Bio*One Capital. For
more information, please visit www.optimedica.com.
References
1 2011 Market Scope Report on the Global Cataract Equipment
Market
2 Yanoff M, Duker J. Ophthalmology: Expert
Consult. Third Edition. Mosby; 2008.
3 Cekic O, Batman
C. The relationship between capsulorhexis size and anterior chamber dept
relation. Ophthalmic Surg Lasers. 1999;30(3):185-190.
4
Friedman, NJ, et al., “Femtosecond Laser Capsulotomy,” Journal of
Cataract & Refractive Surgery, 2011 July; 37(7): 1189-1198
5
Palanker, D., et al., “Femtosecond Laser-Assisted Cataract Surgery with
Integrated Optical Coherence Tomography,” Science Translational
Medicine, Vol 2 Issue 58: 1-9 (2010)
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