STAAR Surgical Company (NASDAQ: STAA), the leading developer, manufacturer and marketer of minimally invasive refractive lenses that go inside the eye, today announced the completion of the first procedures to implant its recently CE Mark-approved Visian® Implantable Collamer® Lens (ICL™) V4c design. Dr. Erik Mertens, Medical Director and founder of the Medipolis Eye Centre in Antwerp, Belgium, implanted the Visian ICL V4c model in five eyes with myopia ranging from -6.0 to -8.0 diopters on Friday, June 24th. These are the first procedures under the Company's pre-launch plan for the product in eight sites and 100 eyes before the full market launch in the countries that accept CE Mark approvals.
The Visian V4c design incorporates the KS-AquaPORT™, or KS-AP™, in the center of the ICL optic, to optimize the flow of fluid within the eye. The KS-AP is named after Dr. Kimiya Shimizu who helped pioneer the technology. The CentraFLOW™ proprietary technology eliminates the need for the surgeon to perform a YAG peripheral iridotomy procedure days before the ICL implant, which leads to more comfort for the patient and a more convenient, efficient ICL experience for both the patient and the surgeon. The Company received CE Mark approval for this new ICL technology in April, 2011.
"These surgeries in Belgium are a very important first step in the execution of our plan to launch the latest Visian ICL design in Europe," said Hans Blickensdoerfer, STAAR's President of Europe and Latin America. "Dr. Mertens is a leading refractive surgeon globally recognized for his work in refractive surgery. His experience and continued endorsement of the Visian technology will help us as we expand the market for this product throughout Europe."
"The V4c design offers significant benefits," commented Dr. Mertens. "Since the approval late last year of the expanded range ICL, I have implanted the ICL in patients with as low as -1.5 diopters of myopia. Based on this initial experience, the new V4c design has proven to be more comfortable and convenient for the patient, as well as for me and my staff. Eliminating the iridotomy step puts the ICL procedure on the same level of efficiency as LASIK and it provides as good, if not better, visual results for the patient. There has been no increase in intraocular pressure and the patients are experiencing the same excellent visual results. This latest ICL development eliminates a step in the procedure, and I believe this revolutionary CentraFLOW™ technology will be a game changer for implant-based refractive surgery."
"We are on track with our pre-launch plan to introduce the V4c, beginning at eight sites and 100 eyes in order to establish a strong marketing platform for the full launch," continued Mr. Blickensdoerfer. "Next week, additional implants are scheduled in Spain. The full product launch to markets that accept CE Mark approval will be a primary highlight at the upcoming ESCRS meeting in Vienna during September. The eight surgeons who will be participating in this pre-launch stage are:
- Dr. Jose F. Alfonso Sanchez in Spain
- Dr. Jaime Aramberri Agesta in Spain
- Dr. Mohammed Alaa El-Danasoury in Saudi Arabia
- Dr. Sheraz Daya in the United Kingdom
- Dr. Erik Mertens in Belgium
- Dr. Ludger Hanneken in Germany
- Dr. Roberto Zaldivar in Argentina
- Dr. Daniel Elies Amat in Spain
The Company received CE Mark approval on the Visian ICL V4c for the -0.5 diopter to -18.0 diopters myopic range and +0.5 cylinder power to +6.0 for the Toric ICL models. The comprehensive clinical research conducted by Dr. Kimiya Shimizu, Professor and Chair of the Department of Ophthalmology at Kitasato University in Sagamihara, Japan, demonstrated the benefits of the new V4c design and was very important to the Company's success in receiving regulatory approval.
"We studied the KS-AquaPORT Visian ICL in two clinical trials during 2008 and 2010," said Dr. Shimizu. "These trials were contralateral, meaning that we implanted the ICL with the KSAP in one eye without performing an iridotomy, and we implanted the ICL without the technology in the other eye where iridotomies were performed. The KS-AP technology was aberration free and all visual results were excellent and identical in both the KS-AP and the conventional ICL. The most impressive outcome was the intraocular pressure post-operatively. It was identical and normal in both sets of eyes. Maintaining the natural flow of aqueous within the eye bathes the crystalline lens with nutrients and could serve to further minimize the risk of cataract formation. We have continued to use the technology in our patients since the trials and they are very happy."
"Once again we would like to express our sincere appreciation to Dr. Shimizu for his ongoing pioneering contributions to the enhancements of the ICL technology as well as to the eight surgeons participating in the pre-launch surgical procedures," said STAAR Surgical CEO Barry G. Caldwell. "The port in the ICL is named after Dr. Kimiya Shimizu for his efforts in advancing this technology. The CentraFLOW technology featuring the KS-AP further differentiates our ICL technology with benefits to both patient and surgeon. They are a testament to STAAR's continued research and development capabilities, which have produced five new product approvals planned for market launches during the second half of this year. The Company continues to make excellent progress toward increasing consumer awareness of the Visian ICL and expanding global market share. There now have been over 225,000 successfully completed ICL implants throughout the world."
Research suggests no need for yellow fever vaccine booster after initial dose