Alcon's LenSx® Laser Receives FDA Clearance for Corneal Flap Creation in Corneal Refractive Procedures
Oct 04, 2012
LenSx® Laser is the only femtosecond laser with U.S. FDA clearance for capsulotomy, lens fragmentation, all corneal incisions, and now – corneal flaps.
New modality will offer surgeons greater ability to tailor treatment to meet specific needs of patients needing corneal refractive surgery.
Continues to lead new era in corneal refractive and refractive cataract surgery innovation.
FORT WORTH, Texas, October 4, 2012 – Alcon announced today that the U.S. Food and Drug Administration (FDA) has cleared the additional indication of corneal flap creation for the LenSx® Laser. The new FDA approval allows the Alcon® technology to be used for corneal flap creation in refractive surgical procedures.
With the new indication, the LenSx® Laser platform will provide surgeons the convenience of an additional modality in corneal flap creation in corneal refractive procedures, enabling them to deliver customized treatments based on a patient’s unique anatomy through the use of precision laser technology.
“We are very pleased to further strengthen the LenSx® Laser platform with a new application for corneal flap creation, thus allowing our customers to further tailor treatment to the specific needs of each individual patient,” said Stuart Raetzman, Head of Global Commercial Strategy, Alcon.
Since first introduced in 2011, surgeons and their patients have benefitted from the improved accuracy, reliability and customization the market leading LenSx® Laser technology offers. With more than 200 LenSx® Lasers in 42 countries and 1,000 surgeons trained, there have been over 50,000 cataract procedures performed globally with the LenSx® Laser.
“The rapid uptake of the LenSx® Laser is a clear marker of the exceptional performance and, consequently, strong demand for this growth platform,” Raetzman adds. “We are committed to continue to partner with surgeons to provide innovations for the LenSx® Laser to improve ophthalmic surgical procedures.”
The FDA clearance enables Alcon to build upon its LenSx® Laser market leadership position by now offering surgeons multiple modality options for corneal flap creation prior to corneal refractive surgery, as well as capsulotomy, lens fragmentation and all corneal incisions for cataract surgery.
This new functionality for the LenSx® Laser will become available in 2013. Current LenSx® customers will be able to seamlessly add the corneal flap procdure to their current platform.
About Alcon Alcon, the global leader in eye care, provides innovative products that enhance quality of life by helping people worldwide see better. The three Alcon businesses - Surgical, Pharmaceutical and Vision Care - offer the widest spectrum of eye care products in the world. Alcon is the second largest division of the Novartis Group with pro-forma sales of USD 10 billion in 2011. Headquartered in Fort Worth, Texas, U.S.A., Alcon has 24,000 employees worldwide, operations in 75 countries and products available in 180 markets. For more information, visit www.alcon.com.
For more information about the LenSx® Laser please refer to the accompanying important safety information.
Caution: United States Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner. Indication: The LenSx® Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. Restrictions: • Patients must be able to lie flat and motionless in a supine position. • Patient must be able to understand and give an informed consent. • Patients must be able to tolerate local or topical anesthesia. • Patients with elevated IOP should use topical steroids only under close medical supervision. Contraindications: • Corneal disease that precludes applanation of the cornea or transmission of laser light at 1030 nm wavelength • Descemetocele with impending corneal rupture • Presence of blood or other material in the anterior chamber • Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy • Conditions which would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only) • Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape • Corneal thickness requirements that are beyond the range of the system • Corneal opacity that would interfere with the laser beam • Hypotony, glaucoma, or the presence of a corneal implant • Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease) • This device is not intended for use in pediatric surgery • A history of lens with zonular instability. • Any contraindication to cataract or keratoplasty surgery. Attention: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. Warnings: The LenSx® Laser System should only be operated by a physician trained in its use. The LenSx® Laser delivery system employs one sterile disposable LenSx® Laser Patient Interface consisting of an applanation lens and suction ring. The Patient Interface is intended for single use only. The disposables used in conjunction with ALCON® instrument products constitute a complete surgical system. Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards. The physician should base patient selection criteria on professional experience, published literature, and educational courses. Adult patients should be scheduled to undergo cataract extraction. Precautions: • Do not use cell phones or pagers of any kind in the same room as the LenSx® Laser. • Discard used Patient Interfaces as medical waste. AEs/Complications: • Capsulotomy, phacofragmentation, or cut or incision decentration • Incomplete or interrupted capsulotomy, fragmentation, or corneal incision procedure • Capsular tear • Corneal abrasion or defect • Pain • Infection • Bleeding • Damage to intraocular structures • Anterior chamber fluid leakage, anterior chamber collapse • Elevated pressure to the eye