OptiMedica Gets FDA Clearance for Cataract Surgery System

Global ophthalmic company OptiMedica Corporation has received U.S. Food and Drug Administration (FDA) 510(k) market clearance of its Catalys Precision Laser System for creating single-plane and multi-plane arc cuts and incisions in the cornea during cataract surgery. The system, which was CE Mark approved for these incisions in March, now has the blessing of European and U.S. regulators for this indication as well as capsulotomy (an incision into the capsule that contains the natural crystalline lens of the eye, in order to remove and replace the natural lens with an artificial one) and/or lens fragmentation.

“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 CEO. “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.”

Burkhard Dick, M.D., chairman and head of the University Eye Clinic in Bochum, Germany, was the 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 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 combines a femtosecond (one quadrillionth of a second) laser, an integrated 3-dimensional optical coherence tomography imaging, and OptiMedica’s breakthrough pattern scanning technology in a reported ergonomic, easy-to-use system. The system includes 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, the company claims. Catalys also has a graphical user interface that the company claims is user friendly and simplifies the planning process, minimizing the time the patient is under the dock.

“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,” said William W. Culbertson, M.D., professor of ophthalmology and the Lou Higgins distinguished chair in ophthalmology at Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, Fla., and chair of OptiMedica’s medical advisory board.

OptiMedica officials report that since its international launch in November 2011 and its U.S. launch in February, Catalys has been installed in more than 20 leading ophthalmic practices in seven countries. In addition, the system has been used to perform more than 3,000 laser cataract procedures worldwide.

Sunnyvale, Calif.-based OptiMedica is focused on technology in the cataract therapeutic space.