Bausch + Lomb Receives 510(k) Clearance From FDA For Vitesse

On Apr 27, 2017

Valeant Pharmaceuticals International, Inc.’s 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.”