This article is more than 5 years old. Information may no longer be current.
A walk around the ASCRS exhibit hall
The smaller laser companies had some of the most interesting developments at this year’s meeting.
Click Here to Manage Email Alerts
PHILADELPHIA — I spent two and a half days here walking the floor of the American Society of Cataract and Refractive Surgery exhibit halls to learn about updates and new products. As usual, there was new information on older ophthalmic laser products and new products on display for me to bring to your attention. I learned about exciting new offerings for corrective refractive surgery, for treating ophthalmic diseases, an update on a couple of interesting IOLs and a relatively new laser for removing or reducing wrinkles.
This article reviews some of the business developments in refractive surgery announced surrounding this year’s ASCRS meeting, as well as new products and enhancements to existing products.
All of the usual refractive laser companies — Alcon, Bausch & Lomb, LaserSight, SurgiLight, and Visx (but not Sunrise Technologies) were in attendance. Following, however, are some of the other companies, including some less-well-known ones, making news at the meeting.
Wavefront Sciences
This company is selling its Complete Ophthalmic Analysis System (COAS) wavefront analyzer as a standalone unit for $50,000. About 20 have been shipped in the United States, and another 110 have been installed with Carl Zeiss Meditec’s MEL G70 laser system outside the States. The COAS system was first introduced to the ophthalmic community at the 2000 ASCRS meeting.
The company also introduced its Ophthalmic Optics Aberrometer (OOA) for testing and characterizing contact lenses and IOLs. The device, selling for about $45,000 and set to be available as of last month, can be used for screening the optics of standard, multifocal and customized lenses before insertion into the eye. The device can also be used to screen the optics of human corneas prior to transplantation to identify potential problems before they become serious complications. The OOA is available in two configurations, a horizontal testing bed for IOLs and a vertically mounted device capable of transmissive testing of optics for contact lenses and corneas.
Kera Technology
Kera was started in 1995 when George Huang split off from J.T. Lin at LaserSight and founded the company. He began manufacturing the random/fractal split dual-beam flying spot IsoBeam D200 excimer laser systems in Spain in 1998. (However, I recall seeing it at the 1995 American Academy of Ophthalmology meeting. As I wrote back then, “The laser, called IsoBeam D200 LASIK System, features dual-beam delivery to provide “central island and lateral island-free symmetrical ablation.”)
The lasers are sold internationally, with 29 sites mostly in Spain, other European countries and South America. Clinical trials are scheduled to begin shortly in the United States, probably with George Waring, MD, and Keith Thompson, MD, at Emory University, where either one or two lasers are currently located.
Q-Vis
The company has re-started its Food and Drug Administration clinical trials in Perth, Australia, after correcting an engineering problem found in its laser system. Forty-two eyes have been treated. U.S. trials, which were halted due to undercorrections in some eyes (only two eyes remain undercorrected, according to a company spokesperson), will begin again, along with trials at multiple other sites including Canada.
(A representative of the company said that Q-Vis was the first to try variable spot-size technology — before Visx.)
CIBA Vision
With the recent agreement to take over the Presby Corp. program for plastic inserts to correct presbyopia, CIBA Vision introduced its UltraLink. This diagnostic device determines the proper depth for making the tunnel in which to place the plastic inserts designed for the surgical reversal of presbyopia.
CIBA has a business alliance with UltraLink LLC to copromote the technology. CIBA believes it will be useful both for identifying the proper position for the Presby bands and for its phakic IOLs.
The company also announced a just-concluded deal with Ioannis Pallikaris, MD, for the marketing and distribution rights to his subepithelial separator (SES), an automated microkeratome-based device for use with his sub-epithelial LASIK procedure, or epi-LASIK, as others have called it. The device, along with a suction ring, creates an epithelial flap without the use of alcohol, which allegedly results in faster healing and less pain for the patient. The SES is not currently available in the United States but is expected to be on the market internationally in early 2003.
20/10 Perfect Vision
This German company introduced a femtosecond laser in competition with IntraLase. The difference between the two may be that 20/10 Perfect Vision intends to couple its laser with its wavefront device, currently sold by Visx as the WaveScan.
In addition to producing a curved, contoured “bladeless flap” to preserve the natural shape of the cornea, the femtosecond laser is said to be capable of both stromal lenticle formation and removal and of intrastromal ablation without cutting open the stroma. Because of gas formation within the stroma, the refractive effect may be limited to custom treatments of about 2 D of correction, company representatives said. Higher corrections may require a separate treatment sometime after the first treatment has healed. Intrastromal corrections are expected to be done for myopia and hyperopia and for presbyopia via monovision.
The company expects to begin selling the laser in Europe by the fourth quarter of this year and obtain 510(k) approval for sale in the United States for flap formation, similar to IntraLase, shortly. In addition, the company will begin clinical trials on intrastromal ablation in the next few months. The first clinical sites are expected to be in the United Kingdom, Germany, Italy and Spain.
BioVision
Vladimir Feingold, the inventor of the STAAR ICL, demonstrated his new microkeratome, the patented Visitome 20/10. The unique feature of this device is a bar just above the blade that sets the depth and controls the flap thickness. Flap thickness can consistently be achieved with an accuracy of less than ±5 µm, he said.
He also showed a lamellar tunnel cutter that can produce a stromal pocket of 250-µm depth for placement of a biocompatible lens for presbyopia. He is currently testing four biocompatible materials before making a final selection for clinical trials.
Topcon
I got my first look at this company’s new wavefront device, the KR-9000PW, which is a combination of Shack-Hartmann wavefront and topographer. The company claims it simultaneously checks both ocular (full eye) aberration and corneal surface aberration.
The company plans to sell it as a standalone device, primarily to optometrists who will use it for diagnostic purposes and for contact lens fitting, including for orthokeratology (fitting gas permeable contact lenses to correct vision with overnight wear only). The device sell for about $55,000.
Carl Zeiss Meditec
As you may have heard, the board of directors of both Asclepion and Carl Zeiss Ophthalmics have agreed to a merger of the companies. The new company will be known as Carl Zeiss Meditec AG. The merger was completed in July.
To put this into perspective, remember that Zeiss had already put its Carl Zeiss Jena and Zeiss Humphrey Systems organizations together to make up Carl Zeiss Ophthalmics. Now that entity has been merged with Asclepion-Meditec to form the new company, Carl Zeiss Meditec AG. The new company is expected to have revenues in the range of 250 million euros, putting it among the leaders in the ophthalmic field.
Asclepion introduced its CRS-Master product at ASCRS. This product combines topography and wavefront in an all-inclusive workstation with a new sophisticated software package that can be directly linked to the Meditec excimer laser. It allows the surgeon to integrate flap data, corneal thickness, pupil size, topography and wavefront data to define the ideal ablation profile for each eye. The program includes a tissue-saving mode and a prolate and night vision optimization mode, all built into its algorithms, to lead to the best customized ablation possible.
There is no per-procedure fee being charged. Since Asclepion’s laser system is not yet available in the United States, the package is currently available only for international sales. U.S. clinical trials are planned for later this year.
Lumenis/WaveLight
The LASIK myopia clinical trial data for WaveLight’s Allegretto laser system continues to surpass anything available from any other company, either from FDA clinical trials or from reported retrospective studies. The myopia data is expected to be ready for FDA submission this summer, with approval anticipated by next spring.
The hyperopia data also looks good, with 80% to 85% of treated patients achieving 20/20 in the clinical trial under way, in comparison to data from Alcon and Visx that showed only 43% and 46% achieving 20/20. There is no word yet on when that data will be submitted to the FDA. The company’s wavefront customized ablation study is expected to be started shortly.
Schwind
An official of this company said its new Carriazo Pendular microkeratome is undergoing final producibility checks. It will be introduced into the European market by the end of this summer, into the United States via 510(k) approval by the end of this year and into Japan next year.
This device will replace the Supratome, which had been sold as an OEM product from Moria, in Schwind’s sales catalog. (For more on this microkeratome, see my write-up following last year’s AAO meeting in the Jan. 15, 2002, issue.)
I learned that Schwind has more that 360 refractive laser systems (Keratom multiscans and ESIRIS spot scanning systems) installed around the world, making it the sixth largest excimer laser producer outside the United States.
I also learned that Schwind is among the first excimer laser producers to link online pachymetry using optical coherence tomography (OCT) with its laser. This allows surgeons to see intraoperatively the actual thickness of the flap, rather than the theoretical thickness, and of the ablation and residual corneal thickness. The surgeon can then determine how much tissue has been ablated and how much residual corneal thickness remains.
The Sirius pachymeter, linked to the ESIRIS laser, allows real-time online visualization of the various stages of the LASIK treatment. An article about this technique as performed by Franz Fankhauser, MD, appears in the May 15 issue. As noted in that article, the Sirius pachymeter is a prototype version that, according to Dr. Fankhauser, “still needs to be perfected.” A more effective system for dealing with decentration needs to be created in case the patient loses fixation. Schwind told me that they are working on further improvements to the system.
Haag-Streit International
Haag-Streit also produces a corneal pachymetry system, the HS Pachymeter, which can be used in a similar fashion to the Sirius pachymeter noted above (which I believe comes from Zeiss Humphrey), for inline, real-time optical low coherence reflectometry, to measure corneal thickness to a precision of 1 µm. This device is also in final development and is expected to be launched at this year’s AAO meeting with a 510(k) approval. It will sell for approximately $10,000 and can be mounted onto any Haag-Streit slit lamp. A company spokesperson told me that the company was in negotiations with at least two excimer laser companies for use of this device as an add-on or build-in to their systems.
IntraLase
The IntraLase FS Pulsion laser system appeared to be the “hot” item at this year’s ASCRS meeting. There was a lot of interest by refractive surgeons in acquiring a system to be able to offer “bladeless” or “all laser” intraLASIK.
Surgeons who have the femtosecond laser system for creating microkeratome-less flaps are able to charge a premium for the procedure, in some cases double the fee that is paid back to IntraLase. A company spokesperson said there are currently 18 systems in operation in the United States, with 38 expected to be in use by the end of the year. The company does not sell the laser outright but charges per case based on volume. The charges range from about $120 per case for high volume users to about $200 per case for lower volume users, with an average of about $150 per use.
66 Vision-Tech Co. Ltd
It was interesting to note that this company was positioned directly across from LaserSight, as a poster in the booth showed a direct look-alike copy of the LaserSight LSX laser. A 66 Vision-Tech spokesperson said the AOV-FB excimer laser system the company is selling has allegedly been in operation in hospitals in Beijing and Shanghai, China, since October 1999. The company brochure notes that the laser was certified by the Public Health Ministry of China in June 2000.
According to the company’s brochure, the laser, which sells for $250,000, uses a small flying spot and the Nova laser head, produced by a “famous” laser producer in Germany. (Is this possibly TUI Laser, which also produces the LaserSight laser head?) The company spokesperson also mentioned that the laser had been designed in cooperation with a company called ScopeRich of Allentown, Pa.
66 Vision-Tech’s information was contained in a brochure of ophthalmic products from Suzhou Medical Instrument General Factory of China.
Nidek
This company has introduced several new features to give better integrated control of its laser during use for customized ablations. Included are an improved, newly patented, faster response four-beam infrared eye tracker with pupil registration of the undilated eye; a new cyclotorsion error correction algorithm; and the multispot ablation (called MultiPoint) that was announced at last year’s AAO meeting.
All of these new features are built into the newest model of their EC-5000 laser system, the EC-5000CXII. According to a company spokesperson, the new laser system will be available in the United States by this year’s Academy meeting. He also mentioned that all the new features can be added to existing lasers by surgeons who wish to upgrade.
Tracey Technologies
Just prior to the ASCRS meeting, Tracey announced that it had signed an agreement with Visx giving Visx exclusive worldwide rights to Tracey’s ray tracing technology for use in customized laser vision correction treatments.
I recalled that in October 2000, TLC Laser Eye Centers and Tracey had announced that they had entered into an exclusive worldwide agreement pertaining to the codevelopment, use and marketing of the proprietary Tracey Visual Function Analyzer (VFA) for wavefront guided LASIK. So I asked a Tracey official about the two agreements. He said that since TLC was the largest refractive surgery presence in North America (controlling approximately 25% of refractive procedures) it made sense to leverage TLC’s market presence at the retail level for introducing Tracey’s ray tracing aberrometer in customized ablations. And since Visx has the majority of the U.S. market share of lasers, again, the ability to leverage Tracey’s technology into the Visx network made economic sense.
I subsequently asked Liz Davila, chief executive officer of Visx, why her company had picked up the rights to the VFA, since they already had the Wavescan wavefront diagnostic from 20/10 Perfect Vision. She explained that Shack-Hartmann analyzers do a great job on normal eyes but not so great on abnormal ones. On the other hand, the VFA works better on abnormal eyes. So Visx surgeons who have access to both analyzers should be able to analyze any eye that comes down the pike.
Other ophthalmic lasers
Endo Optiks. This company developed a fully integrated endoscopic cytophotocoagulation (ECP) laser system (diode laser, light source and visualization system contained in a 20 gauge needle/fiber endoprobe) that is now being exclusively distributed in North America by Medtronic-Solan. Endo Optiks retains international marketing rights. The basic unit sells for about $40,000, or for about $50,000 with a microscope filter and five reusable laser endoscopes.
Iridex. During the Association for Research in Vision and Ophthalmology meeting in May, I heard that this company’s study of prophylactic treatment for age-related macular degeneration (PTAMD) had been halted due to poor results. This was a study of treatment of evident dry AMD, to determine whether prophylactic laser treatment before progression to the wet stage of AMD would halt the progression.
I was told at this meeting that the unilateral arm of the study had been halted because of inconclusive results, but the bilateral study is ongoing and still looking good.
The company also introduced at this meeting an EasyFit slit-lamp adapter for its GLx 532-nm green laser as a replacement for argon lasers for photocoagulation. The adapter sells for $8,500 and allows the $30,000 GLx laser to adapt to most existing Zeiss slit lamps mounted with old Coherent laser systems.
LightMed. This Taiwanese company was selling both an ophthalmic green YAG (LightLas 532 for $20,000) and an 810 nm diode (LightLas 810 at $28,000) for photocoagulation and transpupillary thermotherapy procedures. The company claims that the lasers are both FDA and CE approved. The company also has a Pulsa Syl 9000 1064 YAG for capsulotomies and iridotomies.
Quantel. This French company had its line of ophthalmic lasers on display, including its 532-nm diode Viridis, upgradeable with an 810-nm option; its Viridis Lite, with only the 532-nm wavelength; the Viridis Twin multiwavelength, with both 532 nm and 810 nm, with slit lamp adapters for TTT and panretinal photocoagulation; the Optimis YAG for capsulotomy and iridotomy; and the Iridis 810 nm diode for TTT, cyclophotocoagulation, transscleral retinopexy and endocular photocoagulation. The company also sells its Activis 689 nm PDT laser for activating Visudyne.
Laserex. Ellex Medical of Australia, known as Laserex in the United States, a supplier of ophthalmic YAG lasers to both Coherent/Lumenis and Alcon, had its newest solid-state, doubled YAG laser on display, the Integre 532 laser photocoagulator. This model had been introduced last fall at the AAO.
Other news
C&C Vision. This company’s hinged AT-45 accommodating CrystaLens IOL is in clinical trials, with 300 patients having completed their first year this month. More than 2,000 of the lenses have been implanted. A premarket approval filing is anticipated this fall.
Calhoun Vision. This new company is developing a noninvasively adjustable IOL, dubbed the Light-Adjustable Lens (LAL). The polymer backbone of the lens can be adjusted and further cured within the lens capsule by addressing it with a laser beam. This laser treatment slightly changes its shape to give subtle changes in refractive power. In this way, the lens power can be adjusted to make up for slight errors in the initial power of the lens, without the need for explantation or lens replacement.
The LAL is composed of a cross-linked photosensitive silicone polymer and an embedded macromer, which can be polymerized with the appropriate laser wavelength to change the lens’ curvature and shape. In this way the lens power can be either increased or decreased, depending on where the laser light is applied, to correct the ultimate lens power. Theoretically, the adjustments can be made to correct residual myopia, hyperopia and astigmatism. The company has submitted an investigational device exemption to commence human clinical trials later this year.
ICN Pharmaceuticals. For the first time in recent memory, ICN had the exhibit floor to itself with its cosmetic laser for wrinkle reduction. In recent years, a number of other cosmetic laser companies had exhibited their wrinkle removal/wrinkle reduction systems, especially for periocular wrinkle removal. But this year only the NLite laser collagen replenishment (LCR) system was on display.
The NLite is a pulsed dye laser operating at 585 nm that can be used for “lunchtime” facials for wrinkle reduction. The system works beneath the skin surface to stimulate collagen production without causing the surface effects that marred wrinkle reduction/removal with other laser systems used for facial resurfacing. The laser sells for $79,000.
For Your Information:
- Irving J. Arons is managing director of Spectrum Consulting with offices at 4 Harvard St., Peabody, MA 01960; phone and fax: (978) 531-0939; e-mail: iarons@erols.com. Mr. Arons has no direct financial interest in any of the products mentioned in this article, nor is he a paid consultant for any companies mentioned.