Bausch+Lomb announced that the US Food and Drug Administration has granted 510(k) clearance for its Bi-Blade+ dual-port vitrectomy cutter and an Adaptive Fluidics update to the Stellaris Elite Vision Enhancement System. The Bi-Blade+ builds on the company’s dual-port cutter technology, increasing cutting speed to 25,000 cuts per minute while maintaining a 100% open duty cycle. According to the company, the device delivers a 25% higher flow rate compared with the prior Bi-Blade, supporting more efficient vitreous removal.1 Bench and preclinical data also indicate a 62% reduction in cutter vibration at maximum speed, which may enhance surgeon control and tactile feedback during procedures, as noted in the news release.
The Adaptive Fluidics update automates infusion adjustments in response to real-time vacuum changes, aiming to improve intraoperative fluidics management. When used together, Bi-Blade+ and Adaptive Fluidics demonstrated reduced infusion pressure and more consistent intraocular pressure (IOP) stability in testing, with IOP maintained closer to physiologic ranges even under high vacuum conditions.2
“Bi-Blade has been an essential tool for me in a variety of surgeries, including core vitrectomies, vitreous shaving near mobile retina, removal of intraocular tissues and dissections,” said Professor Marco Mura, MD, University of Ferrara, Ferrara, Italy, in the news release. “The increased cut speed that Bi-Blade+ offers paired with the additional control of Adaptive Fluidics promises to further promote stability and efficiency during surgery.”
References
1. Heuer R, Papour A, Higgins G. Vitrectomy flow performance and optimized system settings for retina shaving with 25g, 25,000cpm dual-action vitrectomy probes. Poster presented at: ARVO conference; May 2025; Salt Lake City, UT.
2. Papour A, Hosten L. Intraocular pressure (IOP) optimized performance settings with posterior adaptive fluidics (PAF), and 25 gauge 25,000 cpm dual-action vitrectomy cutters. Invest Ophthalmol Vis Sci. 2024;65(7). Association for Research in Vision and Ophthalmology 2024 abstract 914.