CLIENT PROJECTS: ZEISS
Carl Zeiss Meditec
First commercial prototype of IntraLase femtosecond corneal refractive laser in the laboratory at the Kellogg Eye Center (University of Michigan, Ann Arbor), circa 1999. Gain Consulting managed performance testing of the IntraLase prototype to support the successful regulatory submission for the company's first several 510[k]'s.
Carl Zeiss Meditec developed and commercialized the SMILE procedure that allows ophthalmologists to correct corneal refractive error by precisely cutting with the VisuMax femtosecond laser and then manually removing the resulting thin, lenticular-shaped section of corneal tissue.
Gain Consulting worked with the Zeiss team to carry out scientific investigations resulting in publications in clinical and scientific venues to support regulatory and marketing projects for the SMILE procedure and the VisuMax femtosecond laser platform.
We helped in the design the experimental study design that used extracted human corneal tissues from clinical procedures, the analysis of the resulting scanning electron microscopy images, and in the publication of the results. Designing and conducting these kinds of tests in support of product introductions is a key strength of our firm.
Microscope image of a glass slide with a femtosecond laser scan pattern scribed inside (mag ~100X). Gain personnel assisted in evaluating, characterizing and troubleshooting IntraLase's first commercial femtosecond laser prototype.
<< Scanning electron microscope images of SMILE lenticules extracted from patients undergoing myopia corrections. The surface quality of the lenticules facilitates manual removal and maintains a high degree of optical quality on the interior of the cornea.
Gain provided technical and scientific analyses in support of the first successful FDA 510[k] for a femtosecond laser medical application and helped write, land and manage several SBIR Phase I and SBIR Phase II grants that fueled the initial development of the IntraLase prototypes.
From those early days, IntraLase went on to a successful IPO, followed by an acquisition by Advanced Medical Optics (a division of Abbott Labs), and has now completed over 5 million femtosecond procedures., including the branded iLASIK procedure and the generally known IntraLasik procedures. Gain Consulting is proud to have participated at key early moments in the development of a large and successful new sector of the medical device industry, with a number of corneal refractive and cataract applications and many ophthalmic device manufacturers.