04.27.10

LenSx Femtosecond Laser Receives 510(k) Clearance for Lens Fragmentation

Source: LenSx Lasers Inc.
LenSx Lasers, Inc. today announced FDA clearance of its LenSx femtosecond laser for laser phacofragmentation during cataract surgery. This third LenSx clearance represents a significant breakthrough in the evolution of cataract surgery technology, bringing the precision of the computer-guided LenSx Laser to another critical step of the cataract procedure.

Dr. Stephen G. Slade (Slade & Baker Vision Center, Houston Texas), who performed the initial series of LenSx procedures in the U.S, stated “the LenSx phacofragmentation clearance is an important milestone in delivering the benefits of laser refractive cataract surgery to patients, including the reduced use of ultrasonic power to fragment and remove the cataractous lens.” As published in The Journal of Refractive Surgery, LenSx laser phacofragmentation resulted in a 43% reduction in average phaco power and a 51% reduction in effective phaco time.

The lead author of that study, Prof. Zoltan Z. Nagy (Semmelweis University, Budapest, Hungary), was one of four LenSx clinical investigators presenting results at the April 2010 American Society of Cataract and Refractive Surgery meeting in Boston. Additional reported benefits of the LenSx Laser cataract surgery technology included the ability to deliver a perfectly centered and sized capsulotomy, resulting in more reproducible positioning of the replacement intraocular lens and in the potential for reduced dependence on glasses.

Richard L. Lindstrom, MD, Founder and Attending Surgeon at Minnesota Eye Consultants commented that “femtosecond laser cataract surgery will enhance refractive outcomes, as well as the safety and operating room efficiency of traditional cataract surgery. This third LenSx 510(k) clearance confirms the leadership position of LenSx Lasers with this extraordinarily exciting technology, and makes femtosecond laser cataract surgery a reality for today rather than a promise for the future. We at Minnesota Eye Consultants are anxious to place our order and incorporate LenSx technology into our practice.”

Although cataract surgery is the most frequently performed ophthalmic procedure globally, the current manually applied techniques do not make use of surgical laser technology. Femtosecond lasers have been utilized extensively for LASIK, with over 3 million procedures performed to date. The LenSx Laser is the first and only femtosecond laser that has received FDA clearance for use in cataract surgery.

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