SANTA CLARA, Calif. — September 7, 2011— Global ophthalmic company OptiMedica Corp. has announced that it has received CE mark approval to market its Catalys Precision Laser System for cataract surgery in Europe. Catalys combines a femtosecond laser, integrated Optical Coherence Tomography (OCT) imaging and OptiMedica’s breakthrough pattern scanning technology in an ergonomic, easy-to-use system designed to bring new levels of precision and accuracy to the cataract procedure. OptiMedica expects to ship its first system in Europe in the fourth quarter of 2011.
“This is an outstanding day for patients, physicians and for OptiMedica,” said Mark J. Forchette, OptiMedica president and chief executive officer. “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. Our system’s CE mark approval is a huge achievement made possible by the efforts of OptiMedica’s dedicated and talented team of scientists, engineers and medical advisors to develop and bring this breakthrough innovation to market. We are excited to enter this new stage in OptiMedica’s history, and we look forward to introducing Catalys to markets around the world in the very near future.”
Cataract surgery is one of the most common procedures performed worldwide, estimated at 19 million cases per year.1 While incremental advancements in surgical tools and techniques have been made in recent decades, the conventional procedure still requires physicians to perform several critical steps manually. This manual approach limits predictability and precision, potentially affecting refractive outcomes and complication rates.
With Catalys, physicians have the opportunity to perform cataract surgery with an unsurpassed level of accuracy. The system is currently CE mark approved to deliver capsulotomy (a circular incision in the lens capsule) and lens fragmentation (segmenting and softening of the lens to prepare for removal), with CE mark approval for corneal incisions anticipated in the near future. A clinical study has demonstrated that Catalys delivers marked improvement over manual surgical technique, with key metrics including:
Capsulotomy size, as measured by deviation of capsule diameter from intended target. The average deviation in capsule diameter with Catalys was only 29 microns, as compared to an average deviation in the manual technique of 337 microns;2
Capsulotomy shape, with a score of 1.0 representing perfect circularity. Capsulotomies delivered with Catalys achieved almost 95 percent circularity, with very little spread in outcomes across all eyes. In the manual group, only 77 percent circularity was achieved, with a larger spread in results;2
Capsulotomy centration. Capsulotomies performed with Catalys were within only 77 microns of perfect centration relative to the dilated pupil;2 and,
Ease of lens fragmentation and disassembly. With Catalys, cumulative dissipated energy (CDE) during ultrasound phacoemulsification was reduced by approximately 40 percent.3
“The improvements in precision made possible by the Catalys system are truly remarkable and represent a very significant and exciting advancement in the practice of cataract surgery,” said OptiMedica Medical Advisory Board Chair William Culbertson, M.D., Professor of Ophthalmology, The Lou Higgins Distinguished Chair in Ophthalmology, Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami. “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.”
OptiMedica developed the Catalys system in close collaboration with a Medical Advisory Board of cataract experts from around the world, with the shared objective to deliver unprecedented accuracy and an exceptional experience. Key innovations reflecting this objective 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, the system 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.
OptiMedica’s Catalys Precision Laser System is not for sale in the United States. OptiMedica expects to launch Catalys worldwide in 2011.
1 2011 Market Scope Report on the Global Cataract Equipment Market
2 Friedman, NJ, et al., “Femtosecond Laser Capsulotomy,” Journal of Cataract & Refractive Surgery, 2011 July; 37(7): 1189-1198
3 Palanker, D., et al., “Femtosecond Laser-Assisted Cataract Surgery with Integrated Optical Coherence Tomography,” Science Translational Medicine, Vol 2 Issue 58: 1-9 (2010)