First LASIK Laser Approved By The U.S. Food And Drug Administration.ORLANDO, Fla.--(BW HealthWire)--Aug. 3, 1998--LaserSight Incorporated (Nasdaq: LASE) announces that the U.S. Food and Drug Administration has approved the premarket approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) application for the Kremer Excimer Laser Kremer excimer laser Ophthalmology A laser for LASIK treatment of myopia ± astigmatism. See LASIK. to perform Laser In-Situ Keratomileusis keratomileusis /ker·a·to·mi·leu·sis/ (ker?ah-to-mi-loo´sis) keratoplasty in which a slice of the patient's cornea is removed, shaped to the desired curvature, and then sutured back on the remaining cornea to correct optical error. (LASIK LASIK laser-assisted in-situ keratomileusis. LA·SIK n. Eye surgery in which the surface of the cornea is reshaped using a laser, performed to correct certain refractive disorders such as myopia. ) for correction of myopia myopia: see nearsightedness. , or nearsightedness nearsightedness or myopia, defect of vision in which far objects appear blurred but near objects are seen clearly. Because the eyeball is too long or the refractive power of the eye's lens is too strong, the image is focused in front of the , and myopic astigmatism. This is the only laser to receive FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval for LASIK in the United States. This PMA approval is for a single device, and requires supplemental manufacturing approval by the FDA to manufacture and commercially distribute additional lasers. The FDA approval is for performing LASIK, using a 6-millimeter ablation zone, to treat myopia ranging from -1.0 to -15.0 diopters, with or without astigmatism astigmatism (əstĭg`mətĭz'əm), type of faulty vision caused by a nonuniform curvature in the refractive surfaces—usually the cornea, less frequently the lens—of the eye. ranging from 0.0 to 5.0 diopters. This is the only laser approved by the FDA to treat high myopia up to -15.0 diopters. LaserSight purchased the worldwide rights to commercialize this laser from Dr. Frederic Kremer during July 1997. LaserSight intends to seek the supplemental manufacturing FDA approval necessary to commercialize the system. Although approval for the single site device came subsequent to a contractual deadline requiring FDA approval before July 29, 1998, the company and Dr. Kremer have agreed to extend the unwind provisions related to this deadline. Michael Farris, LaserSight chief executive officer, says, "We congratulate Dr. Kremer on this achievement and are pleased to have assisted him in reaching this important milestone. LASIK has emerged as the procedure of choice among patients and physicians alike. Laser procedure volumes are growing at an accelerated pace, and LASIK is the reason. We intend to seek approval from the FDA to commercialize this laser system so that physicians and patients can be offered a true LASIK workstation." Since the filing of LaserSight's PMA earlier this year, the company has been pursuing FDA approval for its latest-generation scanning technology. Farris adds, "Just as LASIK is the procedure of choice, scanning will be the technology of choice. Scanning technology designed to perform LASIK is the ultimate future of laser refractive surgery." Dr. Kremer, director of Kremer Laser Eye Centers of suburban Philadelphia, says, "I am very pleased with my association with LaserSight and appreciate their support in assisting me with this important achievement. I will give them my complete support as they seek to obtain supplemental manufacturing approval so that other physicians and patients may benefit from having access to this LASIK laser system." Dr. Kremer was one of the first U.S. surgeons to perform refractive surgery in 1980. In addition to being a surgeon, he is an electrical engineer and a graduate of Drexel University and Thomas Jefferson University It began as Jefferson Medical College in 1824. On July 1, 1969 the institution officially became Thomas Jefferson University. The university is made up of three colleges:
LaserSight Incorporated provides technology solutions for laser refractive surgery and other innovative medical applications, especially in the vision correction industry. The company sells its products in more than 30 countries. In the United States, LaserSight's refractive refractive capacity to refract light. refractive error a difference between the focal length of the cornea and lens, and the length of the eye, resulting in myopia or hyperopia. scanning laser system has had a pending pre-market approval application with the FDA since May of this year, and is not yet commercially available in that market. This press release contains forward-looking statements regarding future events and future performance of the company, which involve risks and uncertainties that could materially affect actual results. Investors should refer to documents that the company files from time-to-time with the Securities and Exchange Commission for a description of certain factors that could cause actual results to vary from current expectations and the forward-looking statements contained in this press release. Such filings include, without limitation, the company's Form 10-K, Form 10-Q and Form 8-K reports. CONTACT: Julie Tockman, APR APR See: Annual Percentage Rate Director, Corporate Relations LaserSight Incorporated 314/291-4450, ext. 122 www.lase.com |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion