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Eyes at ASCRS focused on FS laser surgery for cataracts


By Larry Haimovitch

Medical Device Daily Contributing Writer

April 13, 2010

BOSTON – The annual symposium of the American Society of Cataract and Refractive Surgery (ASCRS; Reston, Virginia), has been held here the past few days. Overall attendance appears to be at record levels, as the combination of the relatively close proximity to Europe and an improving healthcare economy has significantly buoyed interest.

The tone of the meeting was quickly established on the first day with a breakfast symposium sponsored by LenSx Lasers (Aliso Viejo, California). The meeting, titled "Refractive Cataract Surgery with the LenSx Femtosecond Laser," drew a standing room only crowd despite the very early starting time as the audience was attracted by a "who's who" roster of cataract and refractive physicians and a discussion of a new technology that has the ophthalmic surgery community buzzing with excitement.

The superlatives that have been used to describe femtosecond (FS) laser cataract surgery, whether it be about the perceived market leader LenSx or from its two principal competitors LensAR (Winter Park, Florida) or OptiMedica (Santa Clara, California), have been nothing short of remarkable. Coincidentally, all three companies are privately-owned and venture capital-backed.

 Richard Lindstrom, MD, founder of Minnesota Eye Consultants (Minneapolis) and one of the deans of the ophthalmic surgery world, said at this symposium that this technology will usher in a "new era of refractive surgery." At an ophthalmic surgery conference in March, Louis (Skip) Nichamin, MD, Laurel Eye Clinic (Brookville, Pennsylvania) stated that "this is tremendous, landscape-changing technology." At this latter conference, Eric Donnenfeld, MD, Ophthalmic Consultants of Long Island (Rockville Centre, New York), indicated that "I expect that we will all be blown away by this technology."

 In a press release during ASCRS, OptiMedica quoted William Culbertson, MD, director of the Cornea Service and Refractive Surgery at the Bascom Palmer Eye Institute, University of Miami saying that " . . . we are literally changing the face of cataract surgery as we know it today."

The reason for this ebullience is that FS laser cataract technology promises to automate what has historically been essentially a manual procedure, highly dependent on the skill and experience of the surgeon. While the busiest and most talented physicians generally have outstanding results, the "average" surgeon often achieves a sub-optimal result. Some of the potential advantages of this technology are shown in Table 1.

Speaking at the LenSx meeting, Michael Knorz, MD, medical director of the FreeVis LASIK Center (Mannheim, Germany), cited an article in the October 2006 issue of the Journal of Cataract & Refractive Surgery that revealed a 0.8% rate of anterior capsule tears in a study of nearly 2,500 cataract procedures. Amongst ophthalmic surgical residents, the rate of capsule tears was an alarming 5.3%.

An anterior capsule tear can seriously complicate cataract surgery at any stage and about half these cases require an anterior vitrectomy. Vitrectomy is a surgery to remove some or all of the vitreous humor from the eye and is an unfavorable result for the surgeon and the patient.

In discussing this technology and its impact on surgeons, one IOL industry pundit told Medical Device Daily that "this technology will make a mediocre surgeon very good and make a very good surgeon really outstanding."

As previously reported (Medical Device Daily, March 12, 2010), LenSx has reported that Stephen Slade, MD, Slade & Baker Vision (Houston), recently performed the first case with the LenSx laser. Slade reported at this meeting that he has now performed a total of 40 cases over the past few weeks. More significantly, he so pleased with the technology that he is using the FS laser to perform the vast majority of his cataract cases.

The enthusiasm for FS laser cataract technology was clearly seen on the floor of the exhibit hall, where the LenSx attractive booth was swarming with surgeons, eager to get their first look and "test drive" of this new device. Although neither LensAR or Optimedica were showing a laser, both companies saw a huge amount of booth traffic.

LenSx has already received two 510(k) clearances for its laser – the first for a capsulotomy and the second for clear corneal incisions (CCIs). Other specific procedural approvals should be forthcoming in the next several months and, according to a company spokesperson, the company will begin to take orders at the October 2010 annual meeting of the American Academy of Ophthalmology (AAO; San Francisco). It appears that it could begin revenue shipments before year-end.

While LenSx appears to have clearly leaped into the early lead, both LensAR and OptiMedica are well-positioned to compete. The former has told MDD that they have completed about 300 cases outside the U.S., primarily in Mexico and the Philippines, and believes that it can have a working laser at the AAO this fall. At this point, LensAR does not have any FDA approvals but anticipates these in the coming months.

Its founder, Randy Frey, has a demonstrated record of technological and engineering acumen, having previously founded an excimer laser vision correction company that was sold for a handsome price several years ago.

Meanwhile, OptiMedica is expected to be a viable and vigorous contender in this fledgling sector.

This company has been successful and enjoyed strong growth for several years, addressing the retinal laser market with its proprietary Pattern Scan Laser (PASCAL) technology. According to company officials, Optimedica has treated about 100 eyes in the Dominican Republic with its FS laser and hopes to receive FDA approvals over the next several months.

Like LensAR, OptiMedica has not performed procedures in the U.S., indicating that they may be a few months behind LenSx in the race to the market.

While the fervor for this technology is phenomenal, there are several unanswered questions that will need to be resolved. Foremost is "who will pay for the high cost of this procedure?" According to several industry sources, the cost of manufacturing these lasers, which incorporate real time imaging and a huge amount of custom software, will be in the range of $300,000.

The consensus at the meeting is that very few surgeons will actually outright purchase the laser but will lease it and pay a "per click" fee, similar to what occurred with the femtosecond laser that is used to make a corneal flap in a laser vision correction procedure. While pricing has yet to be established, several industry observers have suggested that the "per click" fee will be in the range of $250 to $350 per procedure.

Medicare and private carriers will not cover this extra expense but will allow the patient to pay for the procedure out of pocket, in accordance with a ruling that was established a few years ago to cover premium IOLs like multi-focals, accomodating and toric varieties

Premium IOLs account for less than 10% of the domestic IOL market and slumped significantly in the past 18 months as the economy declined. So, a critical question is how will patients react to another significant "upcharge" to gain the benefit of an all laser cataract procedure?

Based upon the sentiments expressed at this meeting, ophthalmic surgeons fully expect their patients to pony up. According to Lindstrom, "I believe that this will create vastly better patient outcomes and that patients will be willing to pay extra for this.

 

ASCRS Symposium

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