The mood was primarily upbeat at April's annual meeting of the American Society of Cataract and Refractive Surgery. Most in attendance expected a modest rebound in procedure volumes for 2010. Highlights of the meeting included three new laser systems under development that promise to bring a new level of precision to cataract surgery, along with several next-gen surgical treatments for presbyopia.
Laser Cataract Surgery Comes into Focus at ASCRS
Article preview from Medtech Insight- May, 2010
At this year's annual meeting of the American Society of Cataract and Refractive Surgery (ASCRS), held in Boston in April, the atmosphere was primarily upbeat. After two years of declining refractive surgery procedure volumes, most in attendance shared an expectation for a modest rebound in 2010. ( See Exhibit 1.) Despite the fact that the ophthalmic device market is dominated by three large players, most of the truly innovative technologies are developed and introduced by smaller companies, which was certainly the case at this year's ASCRS. The highlights of the meeting included three new laser systems under development that promise to bring a new level of precision to premium cataract surgery, along with several next-generation surgical treatments for presbyopia.
Laser Refractive Cataract Surgery: First System to Launch This Year
The hot topic at ASCRS 2010 was clearly the upcoming launch of three new femtosecond (FS) lasers designed to bring improved precision and safety to cataract surgery. Developments in this field were widely reported for the first time last September at the 2009 meeting of the European Society of Cataract and Refractive Surgeons (ESCRS), and the first product launch in this category is slated for later this year.
FS lasers have been used in ophthalmic surgery for the past eight years to create corneal flaps for laser-assisted in situ keratomileusis (LASIK). These ultra-fast lasers work by delivering closely spaced spots of energy beneath the tissue surface; by aligning hundreds of thousands of these pulses, cleavage planes are created within tissues without burning or ablating. Three key steps in the cataract surgery procedure are being addressed by the FS lasers: (1) corneal incisions, which are typically created using metal or diamond blades; (2) anterior capsulotomies, which are typically created by tearing tissue using forceps, and (3) lens fragmentation, which is typically performed using ultrasonic phacoemulsification. In addition, the laser may be used to create limbal relaxing incisions (LRIs), which are sometimes used to correct astigmatism during or after cataract surgery.
Given that Medicare reimbursement rates will not be increased to accommodate the added cost of this new laser technology, its initial use in the US will most likely be limited to refractive cataract surgery cases that involve premium intraocular lenses (IOLs), specifically accommodating and multifocal IOLs that correct for presbyopia and toric IOLs that correct for astigmatism, as well as cases involving LRIs.
LenSx Lasers Inc. has emerged as the front runner among the laser cataract companies in the race to the US market and was the only company to display a laser in its booth at ASCRS. By the time of ASCRS, LenSx had received two key 510(k) clearances from the US Food & Drug Administration (FDA), for anterior capsulotomy and for corneal incisions. At the end of April, LenSx received its third key 510(k) clearance, for lens fragmentation. LenSx is planning a full US product launch during the American Academy of Ophthalmology (AAO) meeting this October, at which time the company plans to begin shipping commercial systems. One distinguishing feature of the LenSx system is image guidance using real-time ocular coherence tomography (OCT).
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