FDA clears OptiMedica's Catalys Precision Laser System

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. 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. 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.

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. 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.

"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."