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Broad applications seen for electrosurgical instrument
A host of potential ophthalmic applications, some in the developing world, are generating interest in the plasma blade.
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MIAMI — Cataract surgery may be possible using a plasma energy blade. If this turns out to be true, one physician foresees enormous potential for expanding the reach of cataract surgery in the developing world.
The Fugo Blade (Medisurg), sometimes referred to as the plasma blade or plasma knife, is currently approved in the United States for use in capsulorrhexis in cataract surgery and for repair of lens capsule tears. Other ophthalmic surgical applications are currently being evaluated in other countries.
The Fugo Blade was a subject of the John Sheets Memorial Lecture here at the annual meeting of the American College of Eye Surgeons.
“It cuts better than anything that we have known,” said Daljit Singh, MD, of Punjab, India, who presented the lecture.
The plasma knife is a powerful cutting method that someday may have ophthalmic applications beyond its current U.S. labeling and even medical applications outside eye surgery, said its inventor, Richard Fugo, MD, president of Medisurg Research and Development Corporation. The Fugo Blade is the only electrosurgical unit approved by the Food and Drug Administration for electrosurgical anterior capsulotomy, Dr. Fugo said.
Advantages in using the Fugo Blade for anterior capsulotomy, according to Dr. Fugo, include a capsulotomy time as low as 4 to 5 seconds; easy enlargement of the capsulotomy in seconds; no need for red reflex or viscoelastic; and quick repaire of capsular tears; Radial incisions in the capsule do not spontaneously continue to tear, he said.
Simplifying surgery
“Coming as I do from the developing world, I know the needs there,” said Dr. Singh in his lecture. “The technology has to be safe, simple, cost-effective, efficient and easy to maintain. … There are no funds for complicated equipment that is costly to maintain and soon will be obsolete. So it can be useful for great cataract surgery in the developing world. Since a red reflex is not required, it will be possible to do surgery without a coaxial light microscope. This is good for the developing countries.”
Dr. Singh said he often performs cases at home with a hand-held light and operating loupe.
Many current anterior segment surgical devices, such as machines for phacoemulsification and anterior vitrectomy, coaxial light microscopes and diamond knives, could become optional, he said.
“This small instrument is portable. You can take it anywhere,” he said.
“I think this machine is going to be a great leveler, because it can improve and simplify eye surgery. We’re lucky that a major breakthrough in medical technology has found its first application in ophthalmology.”
Ophthalmic uses
“When it comes to cutting the cataract you can do destruction and extraction of the cataract without using any other instrument. … It is possible that it will replace phacoemulsification,” Dr. Singh said.
“Anterior vitrectomy is very easy to do in primary and secondary lens implantations. It will simply cut the vitreous; no sucking or aspiration will be required. We will not be cutting any unnecessary vitreous, and this will be done without traction on vitreous and retina.”
A capsulorrhexis is created in 5 to 10 seconds of plasma energy activation, Dr. Singh said. A donor cornea can be excised in under 10 seconds, permitting fast harvest of donor corneas without enucleation of the globe. Punctoplasty, dacryocystorhinoplasty and eyelid augmentation are further potential applications.
Precise microincisions can be placed in the cornea for the implantation of stents or for potential refractive purposes, Dr. Singh said. The plasma blade will be effective for patients undergoing refractive lensectomy, since no ultrasound energy will be required.
Glaucoma, retina applications
Dr. Singh sees the blade, with its ability to make 100-µm diameter microincision “tracks,” as a tool to perform a number of intraocular pressure (IOP)-lowering procedures such as iridotomy, iridectomy, sclerectomy and sclerostomy.
“We’ll be able to do all the glaucoma surgeries we are already doing with the plasma blade. All this is possible, even today,” he said. One technique involves making one “monotrack at the limbal-conjunctival margin to lower acute elevated IOP,” he said.
In a small pilot series, excellent IOP reductions have been obtained with this technique, Dr. Fugo told Ocular Surgery News.
Vitreoretinal surgery through a pars plana entry will be possible, according to Dr. Singh.
“It will be easy to cut vitreoretinal bands, to rapidly perform membrane peels, retinotomy or translocation of the macula,” he said.
About the Fugo Blade
The plasma blade is small, portable, battery-operated and has a number of safety controls. Dr. Fugo said he believes the greatest safety control is proper knowledge of its operation by qualified surgeons.
“It is an awesome cutting tool,” Dr. Fugo said. The device’s safe use and proper operation are paramount and critically important. The company has stated that it will provide the electrosurgical units only to qualified eye surgeons who agree to undergo the training deemed necessary by Dr. Fugo to properly and safely employ the electrosurgical device.
According to Dr. Fugo, currently more than a dozen human protocols are being conducted outside the United States using the blade. These protocols range from plastic ophthalmics to glaucoma surgery to vitrectomy.
Exact cut
The plasma blade is matched to an electronic echo device that will exactly control and direct the cutting in a very discriminating manner, protecting adjacent tissue.
“With the electronic echo, you can see exactly where you are. We have infinite control of the penetration of the activated filament with the help of electronic echo,” Dr. Singh said.
In a video, he demonstrated the performance of a capsulotomy, showing how tissue discrimination capability causes the blade to shut off automatically near adjacent tissue.
“That gives you great control over this instrument,” he said.
Heat is produced by the plasma blade in tissue at a rate of 0.3° F per second, a slow rate of temperature increase relative to the short actual cutting time required, Dr. Singh said.
For Your Information:
- Daljit Singh, MD, can be reached at 57 Joshi Colony, Punjab, India; (91) 183-221223; fax: (91) 183-221223; e-mail: daljits@jla.vsnl.net.in. Dr. Singh has no direct financial interest in the products mentioned in this article, nor is he a paid consultant for any companies mentioned.
- Medisurg Research and Management Corporation, manufacturers of the Fugo Blade, can be reached at The Fugo Building, 100 West Fornance St., Norristown, PA 19401; (610) 277-3937; fax: (610) 277-7256; Web site: www.fugoblade.com.