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HomeMynosys Cellular Devices Inc.ZEPTO™ Capsulotomy System receives 510(k) Clearance from FDA

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

Mynosys Cellular Devices, Inc. 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.

John Hendrick, CEO of Mynosys Inc. reports, “Zepto™ already has CE Mark and was launched commercially earlier this year in India and Germany.”  He added, ““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 deep demand for an automated capsulotomy product such as Zepto™ that is easy to use, disposable, inexpensive, and consistently gives a great outcome.”

Mr. Hendrick further states that Zepto™ is a perfect device for integration into phacoemulsification systems and can be easily bundled with other products to provide synergies across the product line. Zepto” is the metric unit of measurement one million times smaller than “femto.”

Research was supported by the National Eye Institute / National Institutes of Health under award no. R44EY021023. The content is solely the responsibility of the authors and does not necessarily represent the views of the NIH.

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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