September 2018


Zepto: more than a capsulotomy device

by Lauren Lipuma EyeWorld Contributing Writer

“We wanted to make sure that not only the highly skilled surgeons could use it, but the average surgeon could use it.”
—David Sretavan, MD

The Zepto handpiece has a collapsible capsulotomy tip whose main component is a low profile, transparent silicone suction cup that houses a thin-walled nitinol capsulotomy ring.

When the Zepto tip is outside of the eye, the push rod is extended to elongate the collapsible tip so that it can fit through corneal incisions 2.2 mm and greater.

Once in the eye, the push rod needs to be pulled back and its tip left at position 1 to allow the suction cup and capsulotomy ring to regain their circular shape. With the tip at position 1, the push rod can provide mechanical stiffness to Zepto’s silicone neck (arrow) and assist the surgeon in positioning the capsulotomy tip at the desired location.
Source (all): Russell Swan, MD

Experts say the automated system provides benefits beyond the capsulotomy that can vastly improve surgical outcomes

The Zepto capsulotomy system (Mynosys Cellular Devices, Fremont, California) entered the U.S. market in June 2017, and since then, surgeons have found the automated capsulotomy device provides numerous clinical benefits. By shortening surgery time, providing consistent, circular capsulotomies, preserving visual axis information during surgery, and reducing risks of some complications, the Zepto device makes complex cases routine and can even extend a seasoned surgeon’s career, according to physicians who use it regularly.
The Zepto system consists of a disposable handpiece with a silicone suction cup and a nitinol ring made of a nickel-titanium alloy. The application of suction forces the nitinol ring against the capsule, and a short pulse of energy causes the ring to create a hole in the capsule, creating a circular, centered capsulotomy in 4 milliseconds.
“It’s a very interesting technology; there’s more to it than first meets the eye,” said Kevin Waltz, MD, chief medical officer of Mynosys, Indianapolis. “We can provide a consistent capsulotomy. We can preserve the visual axis information during surgery. We can likely improve healing after surgery. All of those things add up to it being more than just a capsulotomy device.”
“I think it has immense potential in terms of being a tool in the toolbox for those challenging cases,” said Russell Swan, MD, Vance Thompson Vision, Bozeman, Montana. “I would encourage people to become familiar with the technology, even if they have questions about the refractive impact of the capsulotomy.”

Advantages of Zepto

Zepto provides benefits to surgeons over both a manual capsulorhexis and the femtosecond laser in a variety of cases, according to Florian Kretz, MD, chief executive officer, Eyeclinics Ahaus-Greven-Raesfeld-Rheine, Germany. He thinks the Zepto system gives him a rounder, more stable capsulotomy compared to a manual capsulorhexis.
“Zepto has become a major part of my procedures,” Dr. Kretz said. “It is the premium procedure for patients not able to afford FLACS [femtosecond laser-assisted cataract surgery].”
Dr. Kretz uses Zepto in patients with severe zonular disorders where he needs additional zonular support and in patients where he expects phimosis, such as young children and those with retinitis pigmentosa. Surgeons can use Zepto on patients with small pupils, white cataracts, and other complicated cases, with the only limitation being an anterior chamber depth of at least 1.8 millimeters, he said.
Zepto offers a significant advantage when operating on white cataracts, according to Drs. Waltz and Swan.
“Here is the classic situation that you worry about with a white cataract: You’re worried about it being under some tension so when you put a little hole in it, you might get an extension, and you get an Argentinian flag sign,” Dr. Waltz said. “With Zepto, it cuts the 360-degree hole simultaneously, so you get instantaneous release of the pressure. You don’t have to worry about an Argentinian flag sign.”
“Because you have a 4-millisecond capsulotomy, I am even more comfortable [with Zepto] than with the femto, and the strength and stability of the capsule with it is fantastic,” Dr. Swan said. “I think that it’s a game changer there.”
Zepto can even provide benefits for pediatric cataracts. Because pediatric capsules are much more elastic and behave differently during surgery, creating the capsulotomy is difficult. But Zepto has the potential to make these surgeries faster, easier, and safer for the patient, according to David Sretavan, MD, co-founder of Mynosys.
“We’ve had a lot of pediatric cataract surgeons contact us because they see this as a useful tool to help them create that capsulotomy,” he said. “We’d like to address that. It requires a bit of engineering in terms of coming up with a device that will create a capsulotomy of the appropriate size, but that is something that the company intends to do fairly soon.”
One unexpected benefit of the device is that because the silicone suction cup is transparent, Zepto allows the surgeon to preserve visual axis information typically lost during surgery.
“Everyone has his or her unique visual axis, and Zepto allows the surgeon to customize the placement of the capsulotomy to fit the visual axis of that particular patient,” Dr. Sretavan said. “That’s a benefit of a Zepto capsulotomy, and it feeds into the concept that Zepto is much more than just a capsulotomy device; it has benefits through many different important stages of cataract surgery.”

Advantages to the surgeon

By making complex cases routine and routine cases more consistent, Zepto allows seasoned ophthalmologists to extend their surgical careers, according to Dr. Waltz.
“One of the things that causes people to retire from surgery is inability or [discomfort] achieving a consistent capsulotomy,” Dr. Waltz said. “We’ve had a number of mature surgeons say, ‘This is important for me because I’m going to be able to operate for years longer because now I can be assured of my capsulotomy; the rest of it I’m comfortable with, but I was becoming uncomfortable with my capsulotomy.’”
Dr. Swan sees it as a “definite go-to” for any refractive or premium case. “I think a well-centered capsulotomy that has great optic overlap is important to give the best refractive outcome, and I think it’s a nice add-on for those cases,” he said.
Many surgeons have noticed that after creating a Zepto capsulotomy, it’s as if the hydrodissection is almost or fully complete, and they need to do very little in terms of fluid injection to get the lens to spin and rotate freely, according to Dr. Sretavan.
Zepto requires suction to make the capsulotomy, and when the capsulotomy is complete, that suction is released by reintroducing OVD and balanced salt solution into the capsular bag, which creates a 360-degree enclosed hydrodissection effect as part of the device’s removal.
“That has been a benefit that surgeons have told us that they’re seeing, and Mynosys will be optimizing that into Zepto so that more surgeons will have that affect and it will become a reliable result from a Zepto capsulotomy,” Dr. Sretavan said.
The effortless hydrodissection improves healing, which helps prevent postoperative posterior capsule opacification (PCO), according to Dr. Kretz. In addition, the micropulse vibrations that create the capsulotomy help loosen epithelial cells from the capsule, which also helps prevent PCO after surgery, he said.

Zepto vs. femto

The surgeons agree that Zepto and femto are complementary devices for creating automated capsulotomies. While there is overlap between the two, each technology has particular advantages. The femtosecond laser can soften and fragment the nucleus and make incisions, which Zepto cannot do. But Zepto fits more easily into the flow of surgery, can be used with small pupils, is more affordable, and does not put any extra energy into the eye.
“Instead of using capsulorhexis forceps, they hand me the Zepto device, I insert it, do the capsulotomy, then move on, and it doesn’t add any time or inconveniences in terms of the efficiency of our OR flow,” Dr. Swan said.
Zepto is intended to be more of a mass-market device than the femtosecond laser, according to Dr. Sretavan.
“We wanted to make sure that not only the highly skilled surgeons could use it, but the average surgeon could use it,” he said. “There are great surgeons out there who can do a manual [capsulorhexis] very well by hand, and they do it fast, but not everyone is like that.
“For a lot of surgeons, a Zepto capsulotomy is quicker, it’s more consistent, they get the size that they want, and the sizing comes with the benefits of a ‘perfect’ capsulotomy that the field has known about for a long time.”
One of the unique features of the technology is that it’s flexible; there’s a low barrier to entry, Dr. Sretavan continued. “You don’t have to commit half a million dollars and a whole room and hire a new technician to adopt the technology.”

Editors’ note: Dr. Sretavan and Dr. Waltz have financial interests with Mynosys Cellular Devices. Dr. Kretz has financial interests with Vision Ophthalmology Group (Frankfurt, Germany). Dr. Swan has no financial interests related to his comments.

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