OptiMedica Receives FDA Market Clearance of the Catalys™ Precision Laser System

SANTA CLARA, Calif. — December 22, 2011— 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 market clearance 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.

source: OptiMedica