Bausch + Lomb Receives 510(k) Clearance from FDA for Vitesse Vitrectomy System

Source: Bausch + Lomb

Wednesday, April 26, 2017 | FDA Approval/Clearance , Bausch+Lomb


Bausch + Lomb announced that it has received 510(k) clearance from the FDA for Vitesse, the first and only hypersonic, 100% open port vitrectomy system, according to a company news release. This new technology will be featured exclusively on the new Stellaris Elite Vision Enhancement System.

“The ongoing development of Vitesse is an exciting example of Bausch + Lomb’s commitment to advancing retinal surgery technology for the benefit of both doctors and patients,” Chuck Hess, vice president and general manager, U.S. Surgical, Bausch + Lomb, said in the news release. “We believe this technology holds tremendous promise, and are extremely proud to begin introducing it to the market later this year as part of the launch of Stellaris Elite.” 

Vitesse features a novel, single lumen design with a fixed open-port for a consistent flow. Vitesse creates a highly localized tissue liquification zone to liquefy the vitreous at the edge of the port before aspiration. Vitreous removal is currently performed with a guillotine style vitrectomy cutter, a cutting mechanism introduced 40 years ago, which is still used to perform vitrectomies today. This pneumatically driven vitrectomy cutter employs a needle-inside-a-needle design to perform a guillotine cut of the vitreous which is then aspirated.

“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,” Paulo Stanga, MD, 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, said in the news release. “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.”

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 broad range of accessories and probes, including Vitesse.  

“Vitesse is a fundamentally different method of vitreous removal and tissue dissection that may provide greater surgical precision and efficiency than conventional pneumatic vitrectomy cutters,” said Carl Awh, MD, a vitreoretinal surgeon from Nashville, TN. “I am eager to explore the potential of this fascinating new technology.”


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