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Vitesse vitrectomy system receives 510(k) clearance

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Vitesse, a hypersonic vitrectomy system, has received 510(k) clearance from the FDA, according to a press release from Bausch + Lomb.

Vitesse, which will be available exclusively on the Stellaris Elite vision enhancement system, uses a single lumen design and a fixed open-port system, the release said.

The Stellaris Elite system received clearance earlier this month from the FDA.

“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, U.K., said in the 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.”

Bausch + Lomb plans to introduce Vitesse later this year as part of the Stellaris Elite launch, the release said.