STAAR Surgical announced that it has received CE mark approval for its proprietary foldable IOL injector system (KS-X preloaded hydrophobic acrylic injector), which is used in minimally invasive cataract surgery procedures.
-STAAR Surgical announced that it has received CE mark approval for its proprietary foldable IOL injector system (KS-X preloaded hydrophobic acrylic injector), which is used in minimally invasive cataract surgery procedures.
The approval allows the company, which has offered the device in the Japanese market for 2 years, to market the delivery system in the European Union and other countries that recognize the CE mark. The approval also signifies that the system complies with applicable safety and quality standards, according to a prepared statement issued by the company.
“Receipt of the CE mark is an important accomplishment and a validation of STAAR Japan’s expertise in the development of preloaded delivery systems for foldable IOLs that enable precise delivery of the lens during cataract surgeries,” said David Bailey, president of international operations at STAAR Surgical.
“The outstanding functionality of our preloaded system has already won market share in the more difficult silicone segment, and this approval allows us to bring the technology to the growing number of surgeons who prefer the hydrophobic acrylic lenses for their patients,” he continued. “With the introduction of this product in these markets, we believe we are moving toward our goal of establishing our preloaded delivery systems as the global standard of care in all IOL lens segments.”
The first shipments of the product in key European and Australian markets are expected to begin late this month. The device is not approved for sale in the United States.