Valeant's Subsidiary Earns FDA Clearance
Valeant Pharmaceuticals announced its owned subsidiary Bausch + Lomb received FDA clearance for Vitesse.
Valeant Pharmaceuticals International (NYSE:VRX, TSX:VRX) announced its owned subsidiary Bausch + Lomb received 510(k) clearance from the US Food and Drug Administration for their hypersonic vitreous removal Vitesse.
As quoted in the press release:
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.