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06

Bausch + Lomb Receives 510(k) Clearance from FDA for Stellaris Elite™ Next-Generation Phacoemulsification Platform


New Machine Offers Advanced Features, Opportunities for Future Customization


FOR RELEASE THURSDAY, APRIL 6, 2017

BRIDGEWATER, NJ – Bausch + Lomb, a leading global eye health company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Stellaris Elitevision enhancement system, the company’s next generation phacoemulsification 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 maintains constant communication with surgeons and uses feedback to ensure that we are innovating to meet their needs,” said Chuck Hess, vice president and general manager, U.S. Surgical, Bausch + Lomb.  “We know that our customers are looking for a surgical system that will deliver responsiveness and maximum control throughout  every moment of the procedure while having the latest technology machine very cost effectively, and that’s exactly what we’ve designed Stellaris Elite to do.”


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 lens removal.* This system aims to reduce IOP fluctuation and post-occlusion surge through variable infusion pressure in response to changes in vacuum levels. 


The new platform also features Attune® energy management system, which utilizes highly efficient, longitudinal cutting to complement Adaptive Fluidics.  Attune energy management works synergistically with the chamber stability and vacuum efficiency of Adaptive Fluidics to deliver efficient, low energy controlled emulsification.


Bausch + Lomb, the leader in dual function ophthalmic surgical systems, 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 broad range of accessories and probes, including the exciting new Vitesse technology, which is currently under FDA review.   

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 the industry, which is available in more than 100 countries.


*Data obtained in bench study

®/™ are trademarks of Bausch & Lomb Incorporated or its affiliates.
© 2017 Bausch & Lomb Incorporated. SEA.0019.USA.17

 

News Media Contacts:

Kristy Marks
Director, Corporate Communications, Bausch + Lomb
(908) 927-0683 or kristy.marks@bausch.com

 

Teresa Panas

BioComm Network, Inc., on behalf of Bausch + Lomb

(973) 809-8590 or tpanas@biocommnetwork.com  

 

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