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Jul
22
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US FDA approves Abbott’s iDesign Advanced WaveScan Studio System for use in LASIK procedures
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The US Food and Drug Administration (FDA) approved Abbott’s iDesign Advanced WaveScan Studio System and the company launched the product in the market.

The system acts as the “brain” of the LASIK procedure, generating a high-definition scan that measures and maps irregularities of the eye that may impact vision. From these measurements, the iDesign System creates an accurate and personalized LASIK treatment plan based on the unique “blueprint” of each person’s eyes.

The iDesign System captures more than 1,200 micro readings of the eye, as well as identifying the shape of the cornea, its curvature, how light passes through the eye and pupil diameter under different lighting conditions – all in one, three-second scan that can be used to precisely correct vision.

The development of the sensor technology within the iDesign System was the result of an earlier discovery by Abbott scientists, which NASA used to accurately measure and shape the mirrors in the James Webb Space Telescope to ensure it will transmit high resolution images of deep space back to earth. The telescope is scheduled to launch in 2018.

“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. “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.”

In a clinical study on 334 eyes treated with the iDesign System, 99 percent of patients experienced little or no difficulty with the clarity of their vision and 97 per cent of patients had little or no difficulty with their daily activities after surgery. In addition, patients saw significant improvements in their vision while driving at night and a reduction in glare.

“The iDesign System allows doctors to detect details of the eye that we were never able to see before,” said Edward E. Manche, M.D., director of Cornea and Refractive Surgery and professor of Ophthalmology at Stanford University School of Medicine. “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.”

With the 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 iDesign Advanced WaveScan Studio has been approved in several countries around the world since 2012, including China and the European Union.

Abbott, the LASIK market leader and innovator for more than a decade, pioneered the first wave-front guided LASIK technology that transformed the vision correction industry. Abbott’s iLASIK treatment is an all-laser, bladeless procedure that shapes the cornea to help improve a person’s vision. Today, more than 15 million iLASIK procedures have been performed on Abbott machines around the world – with 94 per cent of patients seeing 20/20 or better based on clinical studies. Today’s launch of the iDesign Advanced WaveScan Studio heralds an advance in the use of lasers to correct vision issues.



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