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STAAR Surgical Receives CE Mark Approval for Their SonicWAVE(TM) Phacoemulsification System

  • 2001-04-09
  • Press release

MONROVIA, Calif., April 9 /PRNewswire/ -- STAAR Surgical Company (Nasdaq: STAA) today announced that it received the "CE Mark" for the SonicWAVE(TM) Phacoemulsification System used to remove a cataract lens from the eye. The "CE Mark" approval allows STAAR to begin selling the new system in the estimated $300 million European Union market for cataract removal equipment and accessories. International shipments of the SonicWAVE will begin on April 16, 2001.

"This is an important step in making the SonicWAVE available to the world markets," said David Bailey, President and Chairman of STAAR Surgical Company. "The SonicWAVE offers the cataract and refractive surgeon a reduced-energy fragmentation tool, combined with the option of conventional ultrasound to provide the safest cataract removal system. It is ideal for every type of surgery, without compromising efficiency."

The SonicWAVE(TM) provides a market-ready alternative to ultrasound. Sonic technology offers an innovative means of removing cataract material by using low frequency (40 to 400 Hz) sonic pulses, thereby avoiding the generation of heat and reducing the risk of corneal burns. This has become an increasing area of focus for the industry over recent years. In addition the STAAR UltraVac(TM) coiled tubing creates the highest level of vacuum currently available, up to 600mmHg, while significantly increasing chamber stability. Surgeons can thus operate at these settings while still having the benefits of improved safety. Bailey commented, "Taken together these two features provide the surgeon with a machine which has an unequaled safety profile."

Founded in 1982, STAAR Surgical Company develops, manufactures and globally distributes minimally invasive medical devices for use in refractive, cataract and glaucoma surgery. The Company's principal product line includes foldable intraocular lenses, which are used as replacements for the natural lens in cataract procedures. STAAR also markets two products internationally: an Implantable Contact Lens(TM), which is a refractive lens for the treatment of nearsightedness and farsightedness and the AquaFlow(TM) collagen glaucoma drainage device. All of the Company's products except the Toric ICL(TM) have received the CE Mark for distribution in the European Union.

Certain statements in this press release constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements involve risks and uncertainties that may cause the Company's actual results to be materially different. Factors that could impact the Company's future results are set forth in the cautionary statements included in Exhibit 99 to the Company's latest Form 10-K filed with the Securities and Exchange Commission.

For additional information, visit the Company's web site at or CTC Inc.'s web site or call David Bailey or John Santos at STAAR Surgical Company (626) 303-7902 or Bill Roberts or Ellen Geron at CTC Inc. (937) 434-2700. SOURCE STAAR Surgical Company

CONTACT: David Bailey or John Santos of STAAR Surgical Company, 626-303-7902; or Bill Roberts or Ellen Geron of CTC Inc., 937-434-2700/