Bausch + Lomb Receives 510(k) Clearance From FDA For Stellaris Elite™ Next-Generation Phacoemulsification Platform
New Machine Offers Surgeons Advanced Features and Opportunities for Future Customization
LAVAL, Quebec, April 6, 2017 /CNW/ -- Valeant Pharmaceuticals International, Inc.'s (NYSE: VRX andTSX: VRX) wholly owned subsidiary, Bausch + Lomb, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Stellaris Elite™ Vision Enhancement System, the company's next generation phacoemulsification cataract platform. The new machine offers many new cutting-edge innovations, as well as the opportunity to add upgrades and enhancements continuously, allowing surgeons to customize their machines and expand their capabilities more rapidly than ever before.
"We are pleased to continue to deliver on our planned 2017 product launches with the approval of the Stellaris Elite platform," said Joseph C. Papa, Chairman and CEO of Valeant. "As part of Valeant's continued investment in innovation, this surgical platform will further expand Bausch + Lomb's comprehensive portfolio of products and directly address the needs of the marketplace. By changing the paradigm of traditional large capital equipment currently offered today, our R&D team developed the Stellaris Elite to provide customers innovative upgrades and enhancements every one to two years, versus the customary decade-long life cycle, to meet the ever-evolving needs of their patients."
Stellaris Elite will be the first phacoemulsification platform on the market to offer Adaptive Fluidics™, which combines precise aspiration control with predictive infusion management to create a highly responsive and controlled surgical environment for efficient cataract lens removal.*
Bausch + Lomb plans to launch retina applications for the Stellaris Elite this summer, which will integrate both retina and cataract capabilities into a single machine. The system will also offer surgeons additional functionality and a broad range of accessories and probes, including the new Vitesse technology, a high-speed vitreous cutter, which is currently under FDA review.
About Valeant
Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics. More information about Valeant can be found at www.valeant.com.
About Bausch + Lomb
Bausch + Lomb, a Valeant Pharmaceuticals International, Inc. company, is a leading global eye health organization that is solely focused on protecting, enhancing and restoring people's eyesight. Its core businesses include over-the-counter supplements, eye care products, ophthalmic pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices and instruments. Bausch + Lomb develops, manufactures and markets one of the most comprehensive product portfolios in our industry, which is available in more than 100 countries.
Forward-looking Statements
This press release may contain forward-looking statements which may generally be identified by the use of the words "anticipates, "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the Company's most recent annual or quarterly report and detailed from time to time in Valeant's other filings with the Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes, unless required by law.
*Data obtained in bench study
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SOURCE Valeant Pharmaceuticals International, Inc.
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