VisianÃ‚® ICL and Toric ICL V4c Receive CE Mark Approval
MONROVIA, Calif., April 25, 2011 /PRNewswire/ -- STAAR Surgical Company (NASDAQ: STAA), the leading developer, manufacturer and marketer of minimally invasive ophthalmic lenses for refractive surgery, today announced CE Mark approval for its Visian® Implantable Collamer® Lens (ICL™) V4c design. The V4c design incorporates a proprietary port in the center of the ICL optic of a size determined to optimize the flow of fluid within the eye, and eliminates the need for the surgeon to perform a YAG peripheral iridotomy procedure days before the ICL implant. The result is more comfort for the patient and a more convenient, efficient ICL experience for both the patient and the surgeon. Both myopic and myopic toric models of the ICL will feature the new design. The Company has two issued patents on the technology to enhance flow within the eye and is pursuing additional claims to further broaden its intellectual property position.
The clinical research on the technology was performed by Dr. Kimiya Shimizu, Professor and Chair of the Department of Ophthalmology at the Kitasato University in Tokyo, Japan. Dr. Shimizu performed the first phase of the trials in 2008 when he implanted six patients with the current ICL in one eye and the new V4c design in the second eye. Iridotomies were performed in the eyes with the current ICL, but not in the fellow eyes with the new V4c design. Dr. Shimizu completed the second phase of the study in 2010 when he followed the same clinical protocol with 19 additional patients. The clinical results showed that eyes with the V4c design had the same intraocular pressure (IOP) post operatively as the fellow eyes with the current ICL model. Dr. Shimizu also evaluated other key outcomes including: visual acuity, contrast sensitivity, stability of refraction, predictability of outcomes and vis