NIDEK Receives CE Mark Approval for NIDEK CV-7000 Phacoemulcification System
-September 9, 2005 - Gamagori, JAPAN -
NIDEK Co. Ltd. announced that it has received CE Mark approval for its newly introduced NIDEK CV-7000 Phacoemulcification System. The new CV-7000 and NIDEK’s Nex-Acri IOL will be launched at this year’s ESCRS Meeting in Lisbon, Portugal. This regulatory milestone clears the way for NIDEK to commercialize and further develop and expand its franchise in the cataract surgery marketplace in Europe, Middle East and Asia - three major markets that NIDEK looks to expand in with its consumable and disposable businesses.
“With this new CE mark approval for NIDEK’s new CV-7000 Phacoemulcification System and the recently launched Nex-Acri IOL, NIDEK’s hydrophobic acrylic foldable IOL, we look to develop and expand our reach into the growing market segments of cataract surgery and intraocular lenses. NIDEK’s excellent diagnostic platform, ophthalmic lasers and now cataract / phacoemulcification systems paired with NIDEK’s IOLs will continue our long-term strategy of growth and market development in Europe, Middle East and Asia,” said Motoki Ozawa, Vice President of NIDEK Co. Ltd. “The new CV-7000 has been used extensively around Asia with great success and excellent clinical outcomes and when paired with the NIDEK Nex-Acri IOL, the two products offer the cataract surgeon advanced technologies at affordable pricing and excellent choice of phaco equipment,” added Mr. Motoki Ozawa.
The NIDEK CV-7000 Phacoemulcification System delivers a new standard in cataract surgery, providing a high-repetitive pulse mode for excellent operability and reduced thermal / heat generation. NIDEK’s Pro-Pedal Mode achieves a high anterior chamber stability providing for greater visualization and fast surgery times. The CV-7000 also delivers improved peristaltic technology, which provides for a faster (up to 40% faster) set-up time compared to conventional phaco systems. The system’s newly designed reusable titanium handpiece delivers 40 kHz of ultrasound for phacoemulcification. In addition to all these unique and advanced features of the NIDEK CV-7000, the system offers a user-friendly color touch-screen for an improved user interface for accurate treatment parameters.
“The NIDEK CV-7000 System delivers a complete and comprehensive phacoemulcification platform for cataract surgery in Asia and now with CE mark approval in Europe and the Middle-East. NIDEK continues to strive to develop and deliver innovative and pioneering ophthalmic equipment to users around the world and with the new CV-7000 and NIDEK Nex-Acri - hydrophobic acrylic foldable IOLs, we forge ahead to establish a strong presence in the area of cataract surgery - an area of growth for NIDEK. NIDEK will distribute both new products through its well-established distributor channel network around Europe and the Middle East in the coming few months. We look forward to making the NIDEK CV-7000 and NIDEK’s Nex-Acri a great success in Europe and the new expansion markets,” noted Mr. Motoki Ozawa
The CE Mark is an indication that a company has met essential health, safety and environmental protection requirements detailed in 22 European Directives covering an array of products including medical devices. The CE Mark allows products to gain access to the EU market, assuring physicians and patients of the safety of the product.
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