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Scleral incision system gets EU approval

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DALLAS — The PresView Scleral Incision system has received the European CE mark, according to its manufacturer. Refocus Group plans to introduce the system in Europe later this year, a company press release announced.

The system is designed for the surgical treatment of presbyopia, open-angle glaucoma and ocular hypertension, according to Refocus. The newly approved system incorporates automated components to help simplify placement of the company’s PresView scleral implants.

The press release states that Refocus Group’s strategic partner, CIBA Vision, plans to introduce the system in selected European markets by year-end. Refocus plans to begin U.S. phase 2 trials of the procedure during the latter part of this year, according to the release.