FDA Clears Cataract Surgery Laser
SANTA CLARA, Calif., Dec. 30, 2011 — OptiMedica Corp., a global ophthalmic device company, received FDA 510(k) market clearance for its Catalys laser, a next-generation cataract surgery system.
Catalys combines a femtosecond laser, integrated optical coherence tomography imaging and proprietary pattern scanning technology in an ergonomic system that allows surgeons to perform image-guided preoperative laser lens conditioning. The FDA cleared the system for capsulotomy (a circular incision in the lens capsule) and lens fragmentation (segmenting and softening of the lens to prepare for removal).
A clinical study published in the Journal of Cataract & Refractive Surgery reported that Catalys produces capsulotomies that are within 30 µm of intended size and 80 µm of intended center, with near-perfect circularity. Laser lens fragmentation with the device was shown to ease lens disassembly, reducing cumulative dissipated energy during ultrasound phacoemulsification by approximately 40 percent.
The system was developed in collaboration with a medical advisory board of cataract experts from around the world.
Catalys was CE mark approved in August 2011 and has since been shipped to ophthalmic centers outside the US.
For more information, visit: www.optimedica.com