SUNNYVALE, Calif.--(BUSINESS WIRE)--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.
“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.
About the Catalys Precision Laser System
Catalys is a next generation laser cataract surgery system that brings unparalleled precision and accuracy and a markedly streamlined workflow to the laser cataract procedure. The system combines a femtosecond laser, integrated 3D Optical Coherence Tomography (OCT) imaging and OptiMedica’s breakthrough pattern scanning technology in an ergonomic, easy-to-use system that delivers a precise, customized procedure for patients. Distinguishing features include a Liquid Optics™ Interface that ensures stable system-patient attachment and optimizes the optical path to the patient’s eye, and a proprietary Integral Guidance™ system that ensures the femtosecond laser pulses are delivered safely and precisely to the intended location. In addition, Catalys features an easy-to-use and elegant graphical user interface designed to simplify the planning process and minimize the time the patient is under the dock. The system is available at leading ophthalmic centers around the world.
Founded in 2004 and headquartered in Sunnyvale, Calif., OptiMedica Corp. is a Silicon Valley-based global ophthalmic device company dedicated to developing performance-driven technologies that improve patient outcomes. Exclusively focused in the cataract therapeutic area, the company has developed the Catalys Precision Laser System to deliver unparalleled precision in cataract surgery through image-guided pre-operative lens conditioning. Catalys is U.S. Food and Drug Administration 510(k) market cleared and CE mark approved for performing capsulotomy and/or lens fragmentation and is also CE mark approved for performing corneal incisions during cataract procedures.
OptiMedica’s legacy of innovation in ophthalmology also includes the development and commercialization of the PASCAL® Method of retinal photocoagulation, which was acquired by Topcon Corp. in August 2010. The company is funded by Kleiner Perkins Caufield & Byers, Alloy Ventures, DAG Ventures, BlackRock Private Equity Partners and Bio*One Capital. For more information, please visit www.optimedica.com.