A Medical Device Daily

OptiMedica (Santa Clara, California) reported FDA clearance of its Catalys Precision Laser System, a laser cataract surgery system that the company says brings precision and accuracy and a markedly streamlined workflow to the laser cataract procedure. Catalys combines a femtosecond laser, integrated optical coherence tomography imaging and OptiMedica's pattern scanning technology in an ergonomic 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 company noted that clinical study results published in the peer-reviewed Journal of Cataract & Refractive Surgery have demonstrated that Catalys delivers 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 during ultrasound phacoemulsification by almost 40%.

“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 Forchette, OptiMedica president/CEO. “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.“

OptiMedica says it is exclusively focused in the cataract therapeutic area, and has developed the Catalys Precision Laser System to deliver unparalleled precision in cataract surgery through image-guided pre-operative lens conditioning.