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Home » FDA clears Bausch & Lomb’s Stellaris Elite cataract system

FDA clears Bausch & Lomb’s Stellaris Elite cataract system

April 6, 2017 By Fink Densford

Valeant Pharmaceutical subsidiary Bausch & Lomb - Stellaris phacoemulsifier

Valeant Pharmaceuticals (NYSE:VRX, TSE:VRX) subsidiary Bausch & Lomb said today it won FDA 510(k) clearance for its Stellaris Elite vision enhancement system.

The system is a next-gen phacoemulsification cataract platform designed for cataract lens removal, and offers improved customization and precise aspiration control with predictive infusion management, Bausch & Lomb said.

“We are pleased to continue to deliver on our planned 2017 product launches with the approval of the Stellaris Elite platform. 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,” Valeant CEO Joseph Papa said in a press release.

The company said it plans to launch retina applications for the Stellaris Elite this summer, looking to integrate both retina and cataract capabilities into the system.

Last November, Valeant was reportedly exploring a sale of its eye surgery business, which could be worth as much as $2.5 billion. The divestiture was rumored to be due to the company looking to shed debt it took on through acquisitions, according to the Wall Street Journal.

Valeant was in discussions with 3rd parties for “various divestitures”, according to the newspaper, although Valeant reportedly wouldn’t give up the contact lenses, solutions and eye drugs that it acquired with its $9 billion purchase of Bausch & Lomb in 2013.

Filed Under: 510(k), Food & Drug Administration (FDA), Optical/Ophthalmic, Regulatory/Compliance Tagged With: Bausch + Lomb, Valeant Pharmaceuticals

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