Precision Laser System Approved for Cataract Surgery in Europe

Yael Waknine

September 12, 2011

September 12, 2011 — The European Commission has granted the Conformité Européenne (CE) mark for a laser system (Catalys, OptiMedica Corp) that is intended to increase the precision of cataract procedures, which often still require clinicians to perform several critical steps manually.

The new device combines a femtosecond laser and integrated optical coherence tomography with an image-guidance system that automatically identifies ocular surfaces and establishes safety zones for the precise delivery of therapy.

Its approval for capsulotomy and lens fragmentation was based on clinical study data showing a marked improvement over manual surgical techniques, as defined by

  • decreases in capsulotomy size, as measured by the deviation of the capsule diameter from the intended target (mean, 29 μ vs 337 μ);

  • improved circularity of capsulotomy shape (95% circularity and little spread in outcomes vs 77% circularity and larger spread in results);

  • improved capsulotomy centration (within 77 μ of perfect centration relative to dilated pupil); and

  • facilitated lens fragmentation and disassembly (40% decrease in cumulative dissipated energy during ultrasound phacoemulsification).

"The improvements in precision made possible by the [new laser system] are truly remarkable and represent a very significant and exciting advancement in the practice of cataract surgery," said William Culbertson, MD, OptiMedica Medical Advisory Board chair, in a company news release. "The system's CE mark approval is a tremendous milestone that rewards years of intense collaboration to deliver the greatest precision and best experience for both surgeon and patient."

Dr. Culbertson is professor of ophthalmology and has been awarded the Lou Higgins Distinguished Chair in Ophthalmology from the Bascom Palmer Eye Institute at the University of Miami's Miller School of Medicine in Florida.

According to the news release, the company anticipates obtaining a CE mark allowing use of the device for corneal incisions and expects a worldwide launch in 2011. It is not currently for sale in the United States.