FDA approves Abbott 3-D Lasik system to improve accuracy, expand indication

The iDesign Advanced WaveScan Studio System--Courtesy of Abbott

The U.S. Food and Drug Administration has approved the iDesign Advanced WaveScan Studio System from Abbott Laboratories ($ABT). The company has already launched the system, which is based on a 3-D map of the eye that's expected to improve the accuracy of Lasik procedures.

The system takes more than 1,200 micro readings of the eye; it also identifies the shape of the cornea, its curvature, how light passes through the eye and pupil diameter under specific lighting conditions. It requires only a single, three-second scan.

Abbott's Lasik business has been suffering for years under the twin burdens of customer consolidation and lower utilization. More than 15 million Lasik procedures have been performed on more than 15 million patients, with 94% of those in clinical studies reporting 20/20 or better vision.

"The iDesign System allows doctors to detect details of the eye that we were never able to see before," said Dr. Edward Manche, director of Cornea and Refractive Surgery and professor of Ophthalmology at the Stanford University School of Medicine, said in a statement.

He added, "After surgery, people who were treated with the iDesign System in a clinical study reported high satisfaction rates, as well as improvements in all areas of vision well-being, such as their quality of vision and vision needed for healthy, active lifestyles."

In a clinical trial in 334 eyes, the iDesign System had 99% of patients reporting little or no difficulty with vision clarity after the Lasik procedure, while 97% reported little or no difficulty in daily activities after surgery. Patients had significant vision improvements including during night driving as well as reduction in glare.

With the FDA approval of the iDesign System, more people may now be eligible for Lasik compared to Abbott's existing WaveScan WaveFront technology. Doctors can treat higher levels of astigmatism in people with nearsightedness, a wider range of pupil sizes, and those who are 18 years of age and older.

The approval also means an expanded Lasik treatment population than with the existing WaveScan WaveFront technology--it's approved for patients with higher levels of astigmatism in people with nearsightedness, a wider range of pupil sizes, and those who are 18 years of age and older. The iDesign Advanced WaveScan Studio has been marketed in several countries in the EU and Asia since 2012.

"The iDesign System for Lasik is a leap forward for laser vision correction in the United States, enabling a highly personalized treatment unique to the vision needs of each person," said Leonard Borrmann, head of research and development for Abbott's vision business, in a statement. "The same technology used to help build NASA's new James Webb Space Telescope, which will allow high-definition views of space, is allowing us to map the human eye with great precision."

- here is the release

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