Global ophthalmic company OptiMedica Corp. has announced that its Catalys Precision Laser System has been CE mark approved for creating single-plane and multi-plane arc cuts/incisions in the cornea during cataract surgery. The approval adds new utility to the next generation laser cataract surgery system, which was previously CE mark approved and U.S. Food and Drug Administration market cleared for capsulotomy and lens fragmentation.
“We are thrilled to be able to extend the system's precision and accuracy benefits to these important surgical steps, as they will further optimize the experience for cataract surgeons and their patients.”
"The CE mark approval for corneal incisions is an exciting development that will allow Catalys to bring even more value to the laser cataract procedure," said Mark J. Forchette, OptiMedica president and chief executive officer. "We are thrilled to be able to extend the system's precision and accuracy benefits to these important surgical steps, as they will further optimize the experience for cataract surgeons and their patients."
The new CE marked indication allows cataract surgeons to perform arcuate incisions of precise orientation, length and depth; multi-plane cataract incisions that are designed to be self-sealing; and single plane sideport incisions. Prof. Burkhard Dick, chairman and head of the University Eye Clinic Bochum, Germany, was the first cataract surgeon in Europe to use Catalys for performing these incisions.
"I believe that Catalys represents the forefront of innovation in laser cataract surgery, and it's been my pleasure to break new ground by using the system for corneal incisions," said Prof. Dick. "Catalys has proven to be a very valuable addition to my practice, and I look forward to continuing to work with OptiMedica to set the new standard in laser cataract surgery."
The Catalys system's corneal incisions application is delivered via a software upgrade from OptiMedica and is expected to be available in markets worldwide, pending additional regulatory clearances.
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