Premier Laser Submits Clinical Data For Cataract Procedure to FDA

Premier Laser Systems (Irvine, CA) has submitted data on laser cataract emulsification to the FDA for review and preliminary consideration, pursuant to FDA approval of the procedure. This technique involves the use of Premier's Centauri Er:YAG laser to emulsify cataract tissue and an associated irrigation/aspiration device to withdraw the emulsified material from the eye.

Clinical trials for the procedure have been conducted at four clinical locations in the United States. Leading ophthalmic professionals worldwide have also been testing the system for the past couple of years. The company is currently awaiting a response from the FDA as to the sufficiency of the data for final submittal.

If approved, surgeons say this procedure may provide a variety of benefits to cataract patients, including less eye trauma and less temperature rise during the procedure than with phacoemulsification, the standard ultrasound removal method. They also point to the relative ease of use of the Centauri laser for this procedure.