OptiMedica Catalys Precision Laser System for creating corneal incisions receives FDA 510(k) clearance

Global ophthalmic company OptiMedica Corp. has announced U.S. Food and Drug Administration 510(k) market clearance of its Catalys Precision Laser System for creating single-plane and multi-plane arc cuts/incisions in the cornea during cataract surgery. The system, which was CE mark approved for these incisions in March of 2012, is now both CE mark approved and FDA market cleared for this indication as well as capsulotomy and/or lens fragmentation.

“Catalys' corneal incisions application is yet another example of the innovation I have come to expect from OptiMedica”

"OptiMedica developed Catalys to deliver transformative improvements in cataract surgery, and our rapidly growing installed base of systems is a key indicator that we are achieving this objective," said Mark J. Forchette, OptiMedica president and chief executive officer. "Catalys delivers laser cataract surgery without compromise. The system represents a stark difference from first generation laser cataract surgery technologies in that it is very easy to use and has little to no surgeon learning curve; delivers unparalleled precision and consistent performance; and provides an enhanced experience for both surgeons and patients. We are thrilled that we can now offer both U.S. and European surgeons the ability to utilize all of the procedure capabilities of Catalys."

Prof. Burkhard Dick, chairman and head of the University Eye Clinic Bochum, Germany, was first in Europe to use Catalys to perform corneal incisions. To date, he has incorporated this step into more than 150 cataract surgery cases.

"Catalys' corneal incisions application is yet another example of the innovation I have come to expect from OptiMedica," said Prof. Dick. "The improvement the system makes in the quality of these incisions is, once again, considerable. I have found that Catalys' unequaled performance and ease of use have made it the ideal platform for treating my cataract patients, including even the most challenging cases."

Catalys is a next generation laser cataract surgery platform that combines a femtosecond laser, integrated 3D Optical Coherence Tomography (OCT) imaging, and OptiMedica's breakthrough pattern scanning technology in an ergonomic, easy-to-use system. Distinguishing features 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™ mapping system that ensures the femtosecond laser pulses are delivered safely and precisely to the intended location. In addition, Catalys 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' unparalleled precision and performance represent a sea change in the evolution of cataract surgery, and this is true across all of its indications" said Dr. William W. Culbertson, Professor of Ophthalmology, The Lou Higgins Distinguished Chair in Ophthalmology, Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami and chair of OptiMedica's Medical Advisory Board. "Having worked closely with OptiMedica for years to develop this outstanding system, it's very gratifying to see Catalys now available for all of its intended uses."

Since its international launch in November 2011 and its U.S. launch in February 2102, Catalys has been installed in more than 20 leading ophthalmic practices in seven countries. To date, Catalys has been used to perform more than 3,000 laser cataract procedures worldwide.

Videos of corneal incisions performed with Catalys can be viewed at www.optimedica.com/corneal-incisions.