Mr. Wayne Caulder reports

BAUSCH + LOMB RECEIVES FDA 510(K) CLEARANCE FOR BI-BLADE+ DUAL-PORT VITRECTOMY CUTTER AND ADAPTIVE FLUIDICS ADVANCED UPDATE

The United States Food and Drug Administration has granted 510(k) clearance for Bausch + Lomb Corp.'s Bi-Blade+ advanced dual-port vitrectomy cutter and the adaptive fluidics advanced update on the Stellaris Elite Vision Enhancement System.

• Increased cutting speed of 25,000 cuts per minute is designed to minimize retinal traction, increase vitreous flow and reduce infusion pressure fluctuations when used with adaptive fluidics;
• Bi-Blade+ provides an average flow rate increase of 25 per cent, enabling more efficient vitreous removal compared with Bi-Blade;
• The resulting stability, efficiency and control help boost confidence for retina surgeons to deliver exceptional patient outcomes.

"Retinal surgeons who are familiar with our Bi-Blade technology understand the benefits of its dual-port design, 100-per-cent 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 per cent, enabling more efficient vitreous removal compared with Bi-Blade. At maximum speed, Bi-Blade+ also demonstrates a 62-per-cent 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-per-cent 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 to 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 Prof. 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."

Bi-Blade+ indications and important safety information

Indications and intended use: The Bausch + Lomb vitrectomy cutter pouches are intended to cut and remove vitreous from the eye. They are indicated for any ocular condition requiring anterior vitrectomy during anterior segment surgery and for any vitreoretinal condition requiring vitrectomy during posterior or combined surgery.

Compatible equipment: Stellaris Elite Bi-Blade+ accessories are only intended to operate with Bausch + Lomb Stellaris Elite vision enhancement systems with Bi-Blade+ procedure pack compatibility.

Known residual risks and complications include but are not limited to: infection; inflammation; ocular damage; trauma; cataract formation (not applicable in cataract removal procedures); foreign body/particulates in eye; intraocular pressure (IOP) variance that may cause damage to patient's eye; visual impairment; ischemia; allergic reaction; edema.

Attention:  see the instructions for use for detailed directions, proper use, and full risk and safety information

Caution:  federal (U.S.) law restricts this device to sale, by or on the order of a physician

About Bausch + Lomb Corp.

The company's mission is simple -- Bausch + Lomb helps people see better to live better, all over the world. For nearly two centuries the company has evolved with the changing needs of patients and customers, and its commitment to innovation and improving the standard of care in eye health has never been stronger. From contact lenses to prescription products, over-the-counter options, surgical devices and more, the company is turning bold ideas into better outcomes through passion, perseverance and purpose.

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