PAID ADVERTISEMENT FROM ALCON
A New Approach to Membrane Peeling
The FINESSE™ Flex Loop is designed to create a precise edge safely and consistently.
One of the more challenging maneuvers associated with removal of the epiretinal membrane (ERM) and the internal limiting membrane (ILM) is safely creating an edge to lift the membrane prior to peeling. Whether you use a pick, forceps or a diamond-dusted membrane scraper, the goal is the same: to consistently produce a precise edge for rapid, complete peeling. Alcon recently introduced a new single-use Grieshaber® instrument, the FINESSETM Flex Loop, which is specifically designed to create an edge to facilitate removal of the ERM and the ILM with forceps. We asked David S. Boyer, MD, Los Angeles, and Peter K. Kaiser, MD, Cleveland, for their first impressions of this novel instrument.
CONSISTENT EDGES
Diamond-dusted membrane scrapers have a variable contact profile, which means the depth of the “scrape” may be inconsistent and irregular. “Sometimes the scraper, with its little ‘diamond’ flecks, goes deeper into the tissue than intended, which can damage the retina,” Dr. Kaiser says.
The FINESSETM Flex Loop’s nitinol (nickel/titanium) loop is designed for consistency. The thin loop is designed to allow for excellent visibility to the contact area, and the concave-shaped tines are designed to help avoid unnecessary penetration during procedures. The tines penetrate no deeper than 85% of the ILM and not into the retina.1 “The tines grab only the ILM and do not go deeper into the retina, which may happen with scrapers and even with forceps in some cases,” Dr. Kaiser says.
In addition, researchers recently reported that electron microscopy showed large patches of cellular debris on the retinal side of peeled ILM in 3 out of 4 cases in the scraper group and 1 out of 12 cases in the forceps group.2 The Flex Loop is designed for use without loss of particulate matter.
ADJUSTABLE STIFFNESS
The FINESSETM Flex Loop, which is available in 23-, 25- and 27-gauge, has a retractable tip, which allows the surgeon to adjust the length of the loop and, as a result, its stiffness.1 It is easily inserted through valved and nonvalved cannulas.
“Adjusting the length of the loop is quite easy,” Dr. Boyer says. “I started with the loop very lax, then stiffened it slightly and kept the same amount of pressure I had been using. At that point, the membrane was easy to elevate.
“There is a small learning curve just as there is for any new technique or variation in technique, but the learning curve is extremely quick,” Dr. Boyer says. “Within a few cases, I felt quite comfortable.”
INITIAL EXPERIENCE
Both Dr. Boyer and Dr. Kaiser use the pinch technique with forceps to create an edge for ERM/ILM removal, and both surgeons just recently began using the FINESSTM Flex Loop.
“Most of my first cases using the Flex Loop were removal of the ILM, and I was pleasantly surprised,” Dr. Boyer says. “Adaptation was easy. I had no complications or problems. Even in the postoperative period, there was no damage to the internal retina. The Flex Loop appeared to be extremely helpful in elevating those sometimes difficult-to-elevate membranes. That being said, surgeons will have to decide if they feel more comfortable with their present technique or using this instrument. I think in some cases, the Flex Loop may prove to be a better way of elevating the membrane.”
Dr. Kaiser also found the Flex Loop useful in certain difficult cases. “The pinch-and-grab technique usually works well for me,” he says, “but in some cases, such as in some young patients, elevating the ILM can be difficult. Using the Flex Loop for those patients, I was able to elevate an edge of the membrane easily.
“One case in particular stands out,” he says. “It was a very young patient, a myope, and I just couldn’t, for whatever reason, get the ILM peel started. I switched to the Flex Loop and was able to lift it almost instantly. That was one of the more impressive cases.”
Dr. Kaiser has also used the Flex Loop in proliferative vitreoretinopathy (PVR) cases. “Sometimes with a detached retina, it’s difficult to pinch and grab the ILM,” he says. “So I use the Flex Loop to start the ILM peel and then finish it with forceps. In other PVR cases, I was unable to lift some fine, immature epiretinal membranes with the forceps, but they came up easily with the Flex Loop.”
ADD TO YOUR ARMAMENTARIUM
Dr. Boyer and Dr. Kaiser agree the FINESSETM Flex Loop is a worthwhile addition to the surgical armamentarium. “The full extent of the Flex Loop’s utility will be borne out in studies that examine the instrument’s effect intraoperatively,” Dr. Boyer says. “I believe the Flex Loop can be an aid in some difficult cases where my usual techniques are not working quite as well, and I think it has the potential to replace the diamond-dusted membrane scraper, because I think it is less traumatic. Again, that will need to be proven in studies.”
Dr. Kaiser agrees that the Flex Loop may replace the scraper for many surgeons. “With the Flex Loop, it’s difficult to penetrate too deeply,” he says. “If I were currently using a scraper, I would definitely switch. The Flex Loop is safe and easy to use. It’s one of those instruments that if you use it, you understand, the learning curve is quick. I would recommend surgeons, especially new surgeons who like scraping, to try it. See how you like it and go from there.”
REFERENCES
1. Data on file, Alcon.
2. Steel DH, Dinah C, Habib M, White K. ILM peeling technique influences the degree of a dissociated optic nerve fibre layer appearance after macular hole surgery. Graefes Arch Clin Exp Ophthalmol. 2014 July 16. [Epub ahead of print].
FINESSE Flex Loop Important Product Information
Indications for Use: The Finesse™ Flex Loop is a manual ophthalmic surgical instrument intended to aid in ophthalmic surgical procedures. The device may be used in posterior segment surgery to create an edge on a membrane to begin peeling with forceps. The device is provided sterile and is intended for single use.
Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
Warning and Precautions:
It is not recommended to remove the ILM (internal limiting membrane) with the device. Scraping the retina can cause irreversible damage to the nerve fibers. Inspect tip for damage (e.g. burrs, bending or loosening), check loop functionality (extendability), and ensure the loop is fully retracted before inserting instrument into the eye.
Attention: Reference the Directions for Use for a complete listing of indications, warnings, and precautions.