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https://www.marketscreener.com/STAAR-SURGICAL-COMPANY-10951/…

STAAR Surgical : Announces FDA IDE Clinical Study Approval

08/27/2019 | 07:03am EDT

EVO/EVO+ VISIAN\u00ae Implantable Collamer\u00ae Lens for Myopia, and EVO/EVO+ VISIAN\u00ae Toric Implantable Collamer\u00ae Lens for Myopia with Astigmatism

Additional Study Recommendations and Considerations to be Addressed

STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, is today announcing that the FDA in a letter dated August 23, 2019, stated that it has determined that STAAR has provided sufficient data to support initiation of a human clinical study in the United States of the EVO/EVO+ VISIAN\u00ae Implantable Collamer\u00ae Lens for Myopia, and EVO/EVO+ VISIAN\u00ae Toric Implantable Collamer\u00ae Lens for Myopia with Astigmatism.






STAAR, which has been dedicated solely to ophthalmic surgery for over 30 years, designs, develops, manufactures and markets implantable lenses for the eye with companion delivery systems. These lenses are intended to provide visual freedom for patients, lessening or eliminating the reliance on glasses or contact lenses. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. STAAR’s lens used in refractive surgery is called an Implantable Collamer\u00ae Lens or “ICL”, which includes the EVO Visian ICL\u2122 product line. More than 1,000,000 Visian ICLs have been implanted to date and STAAR markets these lenses in over 75 countries.
 
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