Abbott wins FDA nod for Lasik device
Abbott (NYSE:ABT) said today it won FDA premarket approval for its iDesign Advanced WaveScan studio system designed to generate high-definition eye scans used for Lasik surgery.
The system’s sensor technology, developed by Abbott, is also being used by NASA in the James Webb Space Telescope, slated to launch in 2018, Chicago-based Abbott said.
“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. 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,” Abbott vision head of R&D Leonard Borrmann said in a press release.
In a 334-eye clinical study of the device, 99% of patients reported little or no difficulty with visual clarity and 97% of patients had no interruptions to daily activity after the surgery, Abbott said. The patients also reported an improvement in vision while driving at night and reductions in glare.
“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,” Stanford University professor of Ophthalmology Dr Edward Manche said in prepared remarks.
The company hopes the new release will allow more patients to be eligible for the treatment. The iDesign Advanced WaveScan studio system is already approved for use in China and the European Union, Abbott said.