Bausch + Lomb said the FDA has granted 510(k) clearance for the Bi-Blade+ advanced dual-port vitrectomy cutter and the Adaptive Fluidics advanced update on the Stellaris Elite Vision Enhancement System.
“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+ offers these features along with an increased cutting speed of 25,000 cuts per minute. When combined with Adaptive Fluidics, surgeons will experience stability, efficiency and control that will help streamline procedures and deliver exceptional patient outcomes.”
Bi-Blade+ provides an increased flow rate of 25%, enabling more efficient vitreous removal compared to Bi-Blade. At maximum speed, Bi-Blade+ also demonstrates a 62% reduction in cutter vibration compared to Bi-Blade, offering the surgeon optimized feel and comfort toward a stable surgical experience.
The Adaptive Fluidics update automates fluid infusion to the eye in response to real-time vacuum commands from the surgeon, delivering precise and responsive fluidics infusion at every step of a vitrectomy procedure.
These two technologies combine to support and maintain IOP stability and control. When combined with Adaptive Fluidics, Bi-Blade+ demonstrated a 62% reduction in average infusion pressure compared to surgeries in which Adaptive Fluidics was not used. Continuous aspiration also provides consistent intraocular pressure (IOP) stability. In one study, use of Bi-Blade+ with Adaptive Fluidics resulted in a significant improvement in chamber IOP at a range closer to physiologic IOP (10 – 20 mmHg) even during high vacuum levels.
“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. “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.”
