Bausch & Lomb wins FDA 510(k) for Vitesse open-port vitrectomy system

Valeant Pharmaceuticals (NYSE:VRX, TSE:VRX) subsidiary Bausch & Lomb said today it won FDA 510(k) clearance for its Vitesse hypersonic open port vitrectomy system.

The Bridgewater, N.J.-based company touted the newly cleared system as the 1st and only hypersonic 100% open port vitrectomy system, and said it will be exclusively available on the Stellaris Elite vision enhancement system.

“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. 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,” Dr. Paulo Stanga of the University of Manchester said in a prepared statement.

“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. I am eager to explore the potential of this fascinating new technology,” Dr. Carl Awh said in a prepared release.

The Vitesse features a single lumen design with a fixed open-port, and creates a highly localized tissue liquidification zone designed to liquefy the vitreous at the edge of the port pre-aspiration, the company said.

“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. 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,” Bausch & Lomb US surgical GM Chuck Hess said in a press release.

Earlier this month, Bausch & Lomb said 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.

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