This article is more than 5 years old. Information may no longer be current.
OptiMedica receives CE mark for cataract surgery system
Click Here to Manage Email Alerts
SANTA CLARA, Calif. — OptiMedica has been granted CE mark approval by the European Union for the Catalys Precision Laser System to be used in cataract surgery, the company announced in a news release.
The Catalys platform combines a femtosecond laser, integrated optical coherence tomography imaging and a proprietary pattern-scanning technology designed to enhance surgical precision. OptiMedica plans to begin shipping the system in Europe in the fourth quarter, the release said.
"We believe that the field of cataract surgery is in the midst of a revolutionary change, and we expect Catalys to provide leading technology that satisfies the high expectations of surgeons and their patients," Mark J. Forchette, president and CEO of OptiMedica, said in the release.
The Catalys system has CE mark approval for capsulotomy and lens fragmentation and is expected to be approved for corneal incisions in the near future, the release said.
In a clinical study, the Catalys system enabled capsulotomy diameter within 29 µm of the intended target, 95% circularity and centration within 77 µm of perfect centration in relation to the dilated pupil. The device also enabled a 40% reduction in cumulative dissipated energy during ultrasound phacoemulsification, the release said.
The Catalys platform is not approved in the United States.