STAAR Surgical's nanoFLEXâ„¢ CollamerÃ‚® IOL Receives CE Mark Approval
MONROVIA, Calif., April 28, 2011 /PRNewswire/ -- STAAR Surgical Company (NASDAQ: STAA ), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced CE Mark approval for its nanoFLEX™ Collamer® Single Piece IOL which can be injected through a 2.2 mm incision with the nanoPOINT™ Injector System. The nanoFLEX IOL incorporates the Company's proprietary aspheric optic design (patent pending), which is optimized for the naturally curved anatomy of the eye. CE Mark approval allows the Company to market nanoFLEX in the European Economic Area (EEA) and can serve as a foundation for some additional approvals in countries outside the EEA.
Collamer is a highly compressible, unique lens material composed of collagen, a UV-absorbing chromophore, and a poly-HEMA based copolymer. The compressibility of the material allows the lens to be delivered through a small incision in a controlled and predictable manner. The Collamer material provides excellent quality of vision due in part to its anti-reflective surface, which reduces or eliminates the occurrence of glare and halos. In addition, the Collamer material has demonstrated that it induces fewer higher order aberrations than other lens materials. It has a water content of 40% which is over 50% higher than any other FDA approved hydrophilic IOL material. This same material is used to manufacture the Company's worldwide leading refractive lens, the Visian® ICL™.
"The nanoFLEX approval to market in Europe is a very important milestone for STAAR Surgical," said STAAR Surgical CEO Barry G. Caldwell. "The CE Mark approval positions us to build our global IOL strategy to drive premium product sales growth in key and profitable markets throughout the world. The global platform of our current IOL products includes the current silicone