BBI Contributing Editor
NEW ORLEANS, Louisiana — Expanded FDA approvals, new acquisitions and clinical outcomes for light-based devices were reported at the American Academy of Ophthalmology's (AAO; San Francisco, California) annual meeting in November.
Nidek (Fremont, California) received FDA approval for an expanded treatment zone with its EC-5000 excimer laser platform. The optical zone has been enlarged from 5.5 mm to 6.5 mm, so doctors can now treat patients with larger pupils. "We also received expansion of the transition zone from 7.0 mm to 7.5 mm," said Sam Larson, director of marketing at Nidek. The company also received FDA clearance for retinal and glaucoma procedures for its DC-3300 infrared laser. "This laser can be used in combination with various delivery systems, including slitlamps, binocular indirect ophthalmoscopes, endoprobes and transscleral probes," Larson said.
Visx (Santa Clara, California) obtained FDA approval for mixed astigmatism with its Star S2 and Star S3 excimer lasers. The company also released the most recent data on its WavePrint wavefront ablation technology. Six-month follow-up on initially treated eyes from one center and one-week follow-up on a multicenter trial indicates "promising results for achieving superior uncorrected visual acuities with these ablations," said Greg Halstead, senior manager of marketing.
LaserSight Technologies (Winter Park, Florida reported a worldwide distribution agreement of a custom corneal-ablation software planning package from Ligi Technologie Medicali in Italy. The Corneal Interactive Programmed Topographic Ablation (CIPTA) software already "has clinical experience and years of use," noted Bill Kern, senior vice president of corporate development at LaserSight. "This software allows practitioners to plan an ablation which retains the natural prolate shape of the cornea postoperatively." Likewise, the software helps to ensure that "the optical zone is at least as large as the projection of the scotopic pupil on the corneal surface," Kern said. "In many instances, the reason post-LASIK patients have difficulty with their night vision is because the optical zone is smaller than the scotopic pupil size." The CIPTA software was specifically developed for use with LaserSight's AstraScan excimer laser. The software costs $50,000 for the first-year subscription, then less for the second year (which includes a per-procedure fee).
Lumenis (Santa Clara, California) has acquired HGM Medical Laser Systems (Salt Lake City, Utah), a manufacturer of ophthalmic medical laser devices. The purchase price was $9.7 million in cash. "HGM has been marketing laser and delivery systems primarily to the ophthalmology market since the early 1980s," said Tom Brunner, executive vice president of the ophthalmic business unit at Lumenis. "They are one of the early companies in the ophthalmic field. HGM pioneered the endolaser for use in the operating room. And they currently have a very small, compact green diode system called the Elite for the office as well." Brunner said HGM "complements our product lines and allows practices to do more one-stop shopping." HGM has approximately 7,000 lasers installed worldwide, priced from about $25,000 to $75,000.
Lumenis also said it has expanded its limited exclusive global distribution agreement with WaveLight Laser Technologie AG (Erlangen, Germany). Lumenis will now have distribution rights for WaveLight's refractive laser products in most major markets, including the U.S. and Japan, once regulatory approval is received.
Bausch & Lomb (B&L; San Dimas, California) unveiled the Zyoptix Diagnostic Workstation. Priced at $60,000, this modular platform includes a new version of the Orbscan (the Orbscan IIz) and the Zywave aberrometer. According to Paul Lower, senior product manger for diagnostics, "The combination device brings together two powerful diagnostic data sets: total anterior segment analysis via the Orbscan IIz and total refractive error measured as a wavefront via the Zywave." He said this combination of technologies "places the most comprehensive diagnostic data set for refractive surgery all in one system."
B&L also provided an update on its Zyoptix custom ablation clinical trials. "Our six-month follow-up data on the initial 40 patients looks very promising," Lower said. The FDA has also granted permission to expand the study to an additional 300 patients. The company said it expected to complete the expanded enrollment by December.
IntraLase (Irvine, California) said that October marked the start of commercialization of its Pulsion FS (femtosecond) laser as an alternative to the mechanical microkeratome. This laser is being offered strictly under a fee-per-procedure rental program. "As of the end of November, we have seven units installed in the U.S. and have begun to ship units on a regular basis to meet demand," said Trudy Larkins, director of marketing and communications. Besides initial resection of the cornea (the LASIK flap), the company recently received FDA clearance for anterior lamellar eratoplasty. "We have also started feasibility studies for an intrastromal vision-correction procedure in Tijuana, Mexico," Larkins said. U.S. clinical trials will follow early this year.