JUN 06, 2017
The FDA has approved Mynosys’ Zepto capsulotomy system, a disposable handpiece that uses a proprietary combination of calibrated suction and low-energy pulses to produce high-quality capsulotomies.
Inserted through a 2.2-mm incision, the device integrates into the standard cataract surgery routine, creating a capsulotomy independent of pupil size, corneal clarity and lens density. Due to its unique design, the Zepto system can also be used in challenging cases such as small pupils, zonulopathies, corneal opacities and intumescent cataracts.
Dr. David Chang demonstrates a Zepto capsulotomy
Zepto previously demonstrated good results in 2 studies that were published in the February 2016 issue of Ophthalmology. The first study demonstrated that the device could produce complete, round capsulotomies with minimal zonular stress and negligible temperature spikes in live rabbits and human cadaver eyes. A second study showed it created a significantly stronger capsulotomy than a femtosecond laser capsulotomy or a manual continuous curvilinear capsulorhexis. The authors also noted that the Zepto is cheaper than the femtosecond laser, has fewer logistical challenges and reduces overall surgical time.
Dr. David Chang, who served as an investigator on the trials, further discusses the device in this interview from AAO 2016.
“Zepto already has CE Mark and was launched commercially earlier this year in India and Germany. We have seen overwhelming physician interest and reception for Zepto in both countries,” according to John Hendrick, CEO of Mynosys Inc. “We have also 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.”