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Updated 25-gauge vitrectomy system creates sutureless wounds
The second-generation Millennium TSV25 system has an improved insertion mechanism and excellent fluidics, users say.
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The second-generation Millennium TSV25 vitreoretinal surgery system from Bausch & Lomb introduces improvements over the original system while preserving that earlier version’s advantages, according to several users.
The next-generation system, launched at the American Society of Retinal Specialists meeting, includes an easy-insertion 25-gauge entry-site alignment system, an enhanced light pipe that provides greater illumination and an electric high-speed cutter for optimal vitreous removal, according to the manufacturer.
The small-gauge system works best for cases that do not require a lot of complex instrumentation and manipulation of the eye to work in the far periphery, said Tarek S. Hassan, MD, one of the clinical investigators for the system.
“My primary indications for 25-gauge vitrectomy are epiretinal membrane removal, macular hole repair, diabetic macular edema cases, diabetic hemorrhages, proliferative diabetic retinopathy without extensive far peripheral pathology and primary retinal detachment repair without extensive vitreoretinopathy. I use it for greater than 50% of the cases I do,” Dr. Hassan said.
The 25-gauge system creates potentially safer wounds that expose less surface area than traditional 20-gauge instrumentation, he said.
“The new entry alignment system creates self-sealing, sutureless wounds. At the beginning of the case, you easily make small, minimally invasive incisions into the eye to insert the trocars. At the end you pull the trocars out, and no sutures are required to close the eye after vitrectomy,” Dr. Hassan said in an interview.
The original B&L 25-gauge vitreoretinal system was developed several years ago, he said. While that system offered a welcome alternative to larger-gauge vitrectomy instruments, he said, the second-generation system provides better wound construction along with easier cannula insertion.
“The big drawback [with the first generation] was that the entry alignment system was felt to be difficult to insert. The cannulas would sometimes stick at the edge of the wound, and the surgeon would have difficulty getting easy entry into the eye,” Dr. Hassan said. “The second-generation system is tremendously improved, to the point that it is quite easy to insert the new cannulas.”
More versatile system
The first- and second-generation versions of B&L’s 25-gauge entry-site alignment (ESA) system were compared in clinical trials. Investigators also compared the second-generation system to the Alcon Accurus, the only other 25-gauge vitrectomy system currently available.
Investigators evaluated wound structure and fluidics with the two devices. They observed smaller wounds and faster healing with the second-generation B&L device than with the Alcon device, said Philip J. Ferrone, MD, who was involved in the trials.
There was no difference in wound healing between the first- and second-generation B&L systems, Dr. Ferrone said. The major difference observed was that the wounds were easier to make with the second-generation system.
“These wounds heal well. You don’t have to worry about making a hole in the eye and then stitching it closed,” Dr. Ferrone said.
Safer wounds
A larger, beveled trocar is the most significant change on the new 25-gauge ESA, the investigators said. According to B&L, the second-generation cannula has grooves around the hub portion of the insertion system to facilitate entry into the eye, forceps movement and removal.
The idea was to create the tightest-fitting wound to facilitate self-sealing, Dr. Hassan said. The cannula creates a more horizontal, less circular wound, meaning less exposure of surface area and less fluid leakage, he said.
“The initial concern was that if [the cannula] was easier to insert, there would be something given up with the wound, but that is not the case,” Dr. Hassan said.
With the first-generation insertion system, the surgeons had to press the cannula down firmly, he said, but insertion of the new version requires less effort.
No change in fluidics
The redesigned cannula has preserved the control of fluidics in the second-generation system, said Carl Awh, MD, another clinical investigator of the device.
“One significant advnatage of the new cannula is that it preserves the dimensions of the original system,” he said. “The internal diameter of the cannula is slightly larger that that of competing systems.”
Dr. Awh said the larger cannula maximizes infusion flow and allows easier entry and removal of instruments.
“Every fraction of a millimeter is significant at such a small diameter,” he said. “Reducing the friction between the instrument and the cannula minimizes the movement of the cannula during the case and may be one reason that the wounds hwal better with the B&L. The goal should be to have the largest possible wound that remains watertight withoug sutures.”
Fluidics is a potential limitation in a smaller-gauge vitreoretinal system, Dr. Ferrone said.
“You can run into limitations of flow if you make the vitrectomy tube too small,” he said. His clinical study of the new system included an analysis of its fluidics.
“The flow study I did showed that you can achieve adequate fluidics doing a vitrectomy with the 25-gauge instrumentation available,” he said.
Reduced learning curve
The second-generation 25-gauge system has reduced the learning curve for minimally invasive vitreoretinal surgery, Dr. Hassan said. Surgeons had more difficulty becoming acquainted with the smaller, more flexible instruments with the first-generation system. The new system has a stiffer, brighter light probe with a wider spread of light, he said.
“The shaft allows you to move the eye much the way a 20-gauge light pipe does than the previous 25-gauge instruments,” he said.
Regardless of improvements, there will still be a period of adjustment for surgeons adopting a smaller-gauge system, Dr. Ferrone said.
For Your Information:
- Tarek S. Hassan, MD, can be reached at 632 William Beaumont Medical Building, 3535 W. Thirteen Mile Road, Royal Oak, MI 48073; 248-288-2280; fax: 248-288-2265; e-mail: tsahassan@yahoo.com. Dr. Hassan is a paid consultant for Bausch & Lomb. He has no direct financial interest in the products mentioned in this article.
- Philip J. Ferrone, MD, can be reached at 600 Northern Blvd., Suite 216, Great Neck, NY 11021; 516-466-0390; fax: 516-829-0520; e-mail: p_ferrone@hotmail.com. Dr. Ferrone is a paid consultant for Alcon Laboratories and Bausch & Lomb. He has no direct financial interest in the products mentioned in this article.
- Carl Awh, MD, can be reached at 2011 Murphy Ave., Suite 603, Nashville, TN 37203-2176; 615-320-7911; fax: 615-320-0980; e-mail: cawh@aol.com. Dr. Awh is a paid consultant for Bausch & Lomb. He has no direct financial interest in the products mentioned in this article.
- Bausch & Lomb, maker of the Millennium TSV25 Gauge System, can be reached at 180 East Via Verde, San Dimas, CA 91773; Web site: www.bausch.com.
- Jeanne Michelle Gonzalez is an OSN Staff Writer who covers all aspects of ophthalmology, specializing in practice management, regulatory and legislative issues. She focuses geographically on Latin America.