ZEPTO™ Capsulotomy System receives 510(k) Clearance from FDA

Mynosys Cellular Devices, Inc. today announced that it has received 510(k) Clearance from the US Food and Drug Administration (FDA) for the Zepto™ Capsulotomy System for lens capsulotomy during cataract surgery. Zepto™ uses a proprietary combination of calibrated suction and a 4-millisecond multipulse energy algorithm to produce high quality capsulotomies. Zepto™ can be used through a 2.2mm incision and integrates seamlessly into the standard cataract surgery routine to enhance surgical efficiency and patient flow. Electron microscopic and biomechanical peer-reviewed analysis showed the Zepto™ capsulotomy edge to be significantly stronger than that obtained by manual capsulorhexis or femtosecond laser. Due to its unique design, Zepto™ can be used not only in simple cases of cataract surgery but also in challenging cases with small pupils, zonulopathies, corneal opacities, and in intumescent cataracts. Furthermore, by simply using a standard surgical microscope and instructions for patient fixation, Zepto™ provides personalized capsulotomies tailored to the specific visual axis of individual patients to optimize outcome with premium as well as monofocal intraocular lenses.

“Zepto™ already has CE Mark and was launched commercially earlier this year in India and Germany”; says John Hendrick, CEO of Mynosys Inc. “We have seen overwhelming physician interest and reception for Zepto™ in both countries. “Adoption of Zepto™ technology has been strong in the femtosecond arena, but also in the premium IOL segment and the co-morbidity market, particularly in India”. Mr. Hendrick adds. “There is also a tremendous amount of physician interest around the world in various European, Asian, and South American countries, and of course in the United States.” “We have seen a very broad and…

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