Healthcare Industry News: HSMN NewsFeed
News Release - April 26, 2017
Bausch & Lomb Receives 510(k) Clearance From FDA For Vitesse(TM), The First And Only Hypersonic, Open-Port Vitrectomy SystemFirst Major Vitreous Removal Advancement in 40 Years to be Available Through the New Stellaris Elite™ Vision Enhancement System
LAVAL, Quebec, April 26, 2017 -- (Healthcare Sales & Marketing Network) -- Valeant Pharmaceuticals International, Inc.'s (NYSE: VRX and TSX: VRX) wholly owned subsidiary, Bausch & Lomb, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Vitesse™, the first and only hypersonic device for vitreous removal, which uses a novel, single-needle design and a continuously open-port system. This new technology represents the first major vitreous removal innovation in 40 years, and one that will be available exclusively on the company's new Stellaris Elite™ Vision Enhancement System.
"The successful clearance and upcoming launch of Vitesse is another opportunity in our 2017 launch plan, which we believe will provide truly innovative applications for retina surgeons and their patients," said Joseph C. Papa, Chairman and CEO of Valeant. "We look forward to bringing this next evolution, cutting-edge technology to market on our new Stellaris Elite platform."
Earlier this month, Bausch & Lomb received 510(k) clearance from the FDA for the Stellaris Elite Vision Enhancement System, the company's next-generation surgical 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. Bausch & Lomb plans to launch Stellaris Elite for retina applications this summer, which will integrate both retina and cataract capabilities into a single machine. It will offer additional functionality and a broad range of accessories and probes, including Vitesse.
"I feel privileged to have been able to work with Bausch & Lomb in the development of this new technology since its birth in the lab in 2012. This is perhaps the first major technological change in the way we remove the vitreous since the appearance of guillotine vitrectors," said Paulo Stanga, M.D., a professor of Ophthalmology and Retinal Regeneration at the University of Manchester, and a vitreoretinal surgeon for the Manchester Royal Eye Hospital based in Manchester, United Kingdom. "The new hypersonic vitrector is a significant step forward as it has the potential to lead to future advancements with various needle configurations and gauge sizes."
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.
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.
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