Spotlight: Laser Phaco -- An Overview
Irving J. Arons
Ultrasonic phacoemulsification for the removal of cataracts was invented by Dr. Charles Kelman in 1967. Its use in cataract removal has become widespread in the United States, as well as in developed countries around the world, such that it has become the "gold standard" for this application. However, this year for the first time, a laser phaco device cleared the FDA approval process and the company sponsor has begun marketing this system as a safer alternative to phacoemulsification.
The First Approved Laser Phaco Device
This first FDA approved device, the Dodick Laser Phacolysis System, manufactured by A.R.C. Laser, and marketed by its parent company, Laser Corporation, has a long interesting history. It goes back to at least 1991, when ophthalmologist Jack Dodick first presented his concept for performing laser phaco at that year's American Academy of Ophthalmology (AAO) meeting. Over the years, the Dodick device has had several corporate affiliations, including at one time with Johnson & Johnson's Iolab division, before being acquired and brought to market by Laser Corporation.
The laser operates on the principle that shock waves for breaking up the lens nucleus are generated by directing a pulsed Nd:YAG laser at a titanium target. The broken up particles are then sucked up into an irrigation/aspiration system mounted on the working handpiece tip.
Other Laser Phaco Devices
At the 1993 AAO meeting, Paradigm Medical first showed its Photon pulsed Nd:YAG laser phacoemulsification system, for the direct ablation of lens nucleus that was sucked into an opening in its irrigation/aspiration handpiece, while a photon trap collects any heat produced by diffused laser light. After first trying to obtain FDA approval with minimum clinical trials, Paradigm finally realized it had to go through the full clinical effort, and now claims to be about six months from obtaining marketing clearance.
Also at the 1993 AAO meeting, Premier Laser Systems showed its erbium:YAG Centauri laser phaco device. This system uses the erbium laser energy delivered via a special fiber tip to directly ablate the lens cortex. According to the former CEO of the company, Colette Cozean, Premier had completed its clinical trials and submitted a PMA to the FDA for marketing clearance. The company received several questions about the submission in January 2000, but never responded to them, and declared bankruptcy the following month. Ms. Cozean was asked by Premier to respond to the questions this summer, and did so during the second week of September, and the company is now waiting for a further response from the FDA.
Although Premier Laser Systems declared bankruptcy in February 2000, it appears that the Premier Centauri laser may still make it to the market. SurgiLight has announced it has acquired the Premier ophthalmic laser technology, including the laser phaco system, with final approval of the purchase by the bankruptcy court expected sometime this Fall. SurgiLight has stated that it intends to vigorously pursue all of the ophthalmic applications for this technology, including laser phaco.
Meanwhile, outside of the United States, at least two companies, both of Germany, Asclepion-Meditec (with it PhacoLase), and WaveLight (with it Adagio system), have successfully brought erbium:YAG laser phaco systems to the European market. To the best of my knowledge, neither company plans to initiate FDA clinical trials necessary to bring their devices into the U.S. market any time soon.
In addition to the laser approaches noted above, there have been several other attempts to introduce low energy sources for cataract removal that would create less damage to ocular tissue than ultrasonic phacoemulsification. Staar Surgical is developing its SonicWave, which uses non-thermal sonic energy, rather than ultrasonic energy, to break up the lens nucleus, eliminating the potential heating element associated with conventional phaco. Also, Bausch & Lomb Surgical in association with Atlantic Technologies' Optex Ophthalmics, is developing the Catarex system, that employs a high speed rotary impeller mechanism to emulsify the cataractous tissue. And a technology called phacogelation, or liquifraction, involves using heated BSS solution to weaken chemical bonds, along with pump pressure to break up the nucleus. This latter technology, which is FDA approved, is licensed to Alcon Laboratories, which is seeking commercialization.
Finally, there is a technique called phacotemisis, developed by Dr. Aniz Anis. It involves adding mechanical rotary energy to standard ultrasonic phaco tips to greatly speed up the phaco process. Alcon Labs was originally involved in the development but, apparently, has pulled out of further development of this technology.
U.S. ophthalmologists currently perform between 1.5 to 1.8 million cataract extractions each year. Nearly all of these are done using ultrasonic phacoemulsification. But, alternative techniques are being sought because of at least two reasons: 1) to do less damage to ocular tissue by using lower energy and cooler techniques; and 2) to reduce the complexity and time involved in removing the cataracts, as well as reducing the size of the probe opening, hopefully, someday, to allow for the injection of a liquid polymer to create an accommodative lens.
The laser phaco approaches on or about to reach the market, can currently accomplish only betwenn 65% to 70% of cataract procedures, as they are not yet capable of emulsifying very hard lens nuclei. This means that between 1 million to 1.3 million procedures could be done with laser or other low energy devices. But, because of the lowered reimbursements to ophthalmologists for cataract removal over the past several years, selling a new technique and a new device to accomplish a procedure that they handle very well today with the ultrasound phacoemulsification equipment available, will be a very high hurdle for laser companies or other low energy device companies to overcome.
Because of this major hurdle, we estimate that for laser devices in particular, that will probably sell for approximately the same price as high-end phacoemulsifiers, will only achieve a market penetration of between 10% to 20% of the target ophthalmologists -- the 20% who do the majority of cataract extractions, the so-called high volume surgeons. Thus, the market for laser phaco devices conceivably consists of the sale of only between 300 to 600 systems in the U.S., and perhaps double that outside the U.S. And this level of penetration could take several years to accomplish.
Based on information obtained at the recent AAO meeting, we believe that there are currently between 15 to 20 Dodick lasers in use in the U.S., and another 40-50 in operation in Europe. The other major player in the international market is Asclepion-Meditec, also with about 40-50 Phacolase systems placed in Europe. Thus, the U.S. market appears to be only minimally saturated, while European market may be about 25% to 35% saturated.