FDA approves Abbott’s iDesign WaveScan Studio system

20 July 2015 (Last Updated July 20th, 2015 18:30)

The US Food and Drug Administration (FDA) has granted approval for Abbott's iDesign Advanced WaveScan Studio system for use in laser assisted in-situ keratomileusis (LASIK) procedures in the US.

WaveScan system

The US Food and Drug Administration (FDA) has granted approval for Abbott's iDesign Advanced WaveScan Studio system for use in laser assisted in-situ keratomileusis (LASIK) procedures in the US.

Acting as the brain of the LASIK procedure, the system generates a high-definition scan that measures and maps irregularities of the eye that are likely to impact vision.

These measurements will enable the system to create an accurate and personalised LASIK treatment plan based on a unique blueprint of each person's eyes.

"The iDesign system allows doctors to detect details of the eye that we were never able to see before."

The system captures 1,200 micro readings of the eye and identifies the shape of the cornea, its curvature and how light passes through the eye, as well as pupil diameter under different lighting conditions.

Abbott vision business research and development head Leonard Borrmann said: "The iDesign System for LASIK is a leap forward for laser vision correction in the US, enabling a highly personalised treatment unique to the vision needs of each person.

"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."

The FDA approval follows a clinical study involving 334 eyes treated with the iDesign system, where 99% of patients experienced little or no difficulty with the clarity of their vision and 97% of patients had little or no difficulty with daily activities after surgery.

Stanford University School of Medicine Ophthalmology professor Edward Manche said: "The iDesign system allows doctors to detect details of the eye that we were never able to see before."

"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."

The system has been approved in several countries worldwide since 2012, including China and the European Union. The iLASIK treatment is an all-laser, bladeless procedure that shapes the cornea to help improve a person's vision.

Abbott has performed more than 15 million iLASIK procedures with 94% of patients seeing 20/20 or better based on clinical studies.


Image: Abbott has secured approval from the FDA for its Advanced WaveScan Studio system. Photo: courtesy of Abbott Laboratories.