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STAAR Surgical Gains Final Step in Regulatory Approval for Visian® ICL™ with CentraFLOW® in China

  • 2014-11-04
  • Press release

MONROVIA, Calif., Nov. 4, 2014 /PRNewswire/ -- STAAR Surgical Company (NASDAQ: STAA) a leading developer, manufacturer and marketer of implantable lenses and delivery systems for the eye, today announced that it has received the Approval Certification from CFDA to market its Visian ICL with CentraFLOW® technology in China effective November 3rd. The Visian ICL with CentraFLOW uses a proprietary port in the center of the ICL optic, KS-AquaPORT®, intended to optimize the flow of fluid within the eye without affecting the quality of vision. The CentraFLOW technology eliminates the need for surgeons to perform a YAG peripheral iridotomy procedure days before the ICL implant, simplifying the procedure and increasing patient comfort while providing the superior visual outcomes of the ICL.

"China is currently the largest market in the world for refractive procedures and the approval of the Visian ICL with the CentraFLOW technology builds on the momentum of our already quickly growing line of ICL products in this important focus market" said Don Todd, President of the Asia Pacific Region.  "We have seen a very positive impact in other markets with the introduction of the CentraFLOW technology.  Visian ICL procedures today represent about 2% of the more than 875,000 annual refractive procedures in China. We now have the opportunity to further expand our share and growth in China, which included a 27% ICL revenue growth milestone in the most recent quarter.  The first orders for the Visian ICL with CentraFLOW have been placed and will begin to ship this week."

STAAR Surgical personnel in China began marketing the new technology on Monday.  To date over 400 surgeons have been trained on the Visian ICL technology and additional surgeon training is already underway.  The first orders for the Visian ICL with CentraFLOW were placed yesterday and leading ophthalmologists who were trained during the recent ESCRS meeting will begin utilizing the new technology.  There will be a CentraFLOW training course in China for surgeons in November followed by two additional training courses before year end.  Distributors in China were trained at a recent meeting in September and additional training will take place in November. 

The steps this year in the CentraFLOW's approval process in China started with a successful Experts Panel Meeting on May 15th which was followed by the Technical Recommendation from CMDE on September 24th and the Marketing Approval from the CFDA on October 29th. The approval includes both the Myopic ICL and the Toric ICL with expanded approval ranges for both myopia and astigmatism.  This increases the potential number of patients that can be treated with the Visian ICL in China.  The range of myopia correction approved is -0.5 diopters to -18.0 diopters versus the previous range of -2.5 diopters to -18.0 diopters equivalent in BSS.  The range of astigmatism correction approved is +0.5 to +6.0 diopters versus the previous range of +0.75 to +4.75 diopters equivalent in BSS.  The previously approved ICL was stored in sodium chloride while the Visian ICL with CentraFLOW will be stored in BSS.

About STAAR Surgical

STAAR, which has been dedicated solely to ophthalmic surgery for over 25 years, designs, develops, manufactures and markets implantable lenses for the eye and delivery systems therefor. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. STAAR's lens used in refractive surgery as an alternative to LASIK is called an Implantable Collamer® Lens or "ICL." A lens used to replace the natural lens after cataract surgery is called an intraocular lens or "IOL." More than 475,000 Visian ICLs have been implanted to date; to learn more about the ICL go to: STAAR has approximately 335 full time employees and markets lenses in over 60 countries. Headquartered in Monrovia, CA, it manufactures in Aliso Viejo, CA and Monrovia, CA. For more information, please visit the Company's website at

Safe Harbor

All statements in this press release that are not statements of historical fact are forward-looking statements, including statements about any of the following: any projections of revenue, sales or any other financial items; the plans, strategies, and objectives of management for future operations or prospects for achieving such plans; statements regarding new or improved products, including but not limited to, expectations for success of new or improved products; future economic conditions or size of market opportunities; expected regulatory activities and approvals, product launches, and any statements of assumptions underlying any of the foregoing.  Important additional factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in the Company's Annual Report on Form 10-K for the year ended January 3, 2014, under the caption "Risk Factors," and also in the Company's Quarterly Report on Form 10-Q for the quarter ended July 4, 2014, under the caption "Risk Factors," both of which is on file with the Securities and Exchange Commission and available in the "Investor Information" section of the company's website under the heading "SEC Filings."

These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements.




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EVC Group

Brian Moore, 310-579-6199

Nicole Kruse, 212-850-6025

Doug Sherk, 415-652-9100

SOURCE STAAR Surgical Company