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FDA approves Star S4 IR laser with CustomVue to treat high myopia, astigmatism
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Advanced Medical Optics announced today that the Visx Star S4 IR excimer laser was approved by the U.S. Food and Drug Administration to treat high myopia and astigmatism with the CustomVue procedure.
The treatment is indicated for the reduction or elimination of myopia and astigmatism from –6 D to –11 D with up to –3 D of cylinder, according to a press release issued by AMO.
"The expansion of the CustomVue procedure for highly nearsighted and/or astigmatic individuals adds yet another level of safety, precision and personalization to the laser vision correction procedure,” said Sandy T. Feldman, MD, a contributor to the clinical trials. “In this group of individuals, the improved quality of vision is particularly significant. Almost all individuals who are eligible for LASIK surgery can now be treated with the personalized approach of the CustomVue procedure.”
The Visx Star S4 laser also features the first FDA-approved, fully automated, non-contact method of iris registration to align the correct CustomVue treatment with the cornea, according to company literature.
According to the press release, 98.3% of the patients who received CustomVue high myopia treatment were corrected to 20/40 or better at 6 months, and 84.3% were corrected to 20/20 or better without contact lenses or spectacles.
"I’m excited about having this option for my high myopic patients,” said Colman R. Kraff, MD, who also contributed to clinical trials. “The results from the clinical trial are outstanding. No high myopic results on any other laser platform, past or present, come close to the results that were achieved in this clinical trial.”
Procedures for the newly approved CustomVue treatments will be released to certified Visx surgeons over the next few weeks after they have finished training, according to the release.
"This approval by the FDA further demonstrates the importance of our May 2005 acquisition of Visx Inc. and reinforces the value we have placed on our laser vision correction business,” AMO President and CEO Jim Mazzo said. “The CustomVue procedure is one of the fundamental platforms in our refractive portfolio.”