Bausch + Lomb announced that the FDA has granted 510(k) clearance for two innovations designed to enhance vitreoretinal surgery: the Bi-Blade+ advanced dual-port vitrectomy cutter and the Adaptive Fluidics update for the Stellaris Elite Vision Enhancement System. The newly cleared technologies aim to improve surgical precision, efficiency, and IOP stability.

“Retinal surgeons who are familiar with our Bi-Blade technology understand the benefits of its dual-port design, 100% open duty cycle and cutting speed of 15,000 cuts per minute,” said Wayne Caulder, vice president and general manager, North America Surgical, Bausch + Lomb. “Bi-Blade+ builds on that foundation with an increased cutting speed of 25,000 cuts per minute. When combined with Adaptive Fluidics, surgeons will experience enhanced stability, efficiency and control that can streamline procedures and support exceptional patient outcomes.”

The Bi-Blade+ vitrectomy cutter introduces several performance improvements over its predecessor. It delivers a 25% increase in flow rate, enabling more efficient removal of vitreous material. Additionally, at maximum speed, the device demonstrates a 62% reduction in cutter vibration, which can improve surgical precision and provide a more stable, controlled experience for surgeons, according to Bausch + Lomb. 

The Adaptive Fluidics update represents an advancement in fluid management during surgery. The system automatically adjusts fluid infusion into the eye in response to real-time vacuum commands, allowing for precise and responsive control throughout the procedure.

Together, Bi-Blade+ and Adaptive Fluidics work to maintain consistent IOP. Clinical findings indicate that their combined use results in a 62% reduction in average infusion pressure compared to procedures without Adaptive Fluidics. Continuous aspiration further supports stable IOP levels, helping maintain conditions closer to the physiologic range of 10–20 mmHg, even during high vacuum settings.

“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, of the University of Ferrara in Italy. “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.”