Bausch + Lomb has received FDA 510(k) clearance for two technology innovations: the Bi-Blade+ advanced dual-port vitrectomy cutter and the Adaptive Fluidics advanced update on the Stellaris Elite Vision Enhancement System.
Break these approvals down for me.
We’ll begin with the Bi-Blade+ advanced dual-port vitrectomy cutter.
What it is: A specialized surgical instrument utilized during pars plana vitrectomy to cut and remove vitreous (among other intraocular tissue) from the eye.
- Its indication is for:
- Any ocular condition requiring anterior vitrectomy during anterior segment surgery
- Any vitreoretinal condition requiring vitrectomy during posterior or combined surgery
And take note: The Bi-Blade+ is an upgrade to the original Bi-Blade
Tell me more about its design.
With a dual-edge, dual-port design that cuts in both forward and backward directions (without the need for port closure), the tech also allows up to 25,000 cuts per minute (CPM), targeting:
- Increased flow rates (by 230%)
- Improved stability
- More efficient vitreous removal during retina procedures
See this visual of how it compares to traditional single-port cutters with 7,500 CPM mode.
And how does it stack up against B+L’s original Bi-Blade technology?
The company noted that, at its maximum speed, Bi-Blade+ has demonstrated a 62% reduction in cutter vibration versus Bi-Blade as well as an increased flow rate of 25%.
Check out the clinical data supporting this.
Impressive … now talk about the Stellaris Elite system.
This comprehensive ophthalmic surgical platform is designed for use in both anterior and posterior segment surgeries—with capabilities extending to:
- Phacoemulsification (phaco), coaxial and bimanual irrigation / aspiration, bipolar coagulation, vitrectomy, viscous fluid injection / removal, and air / fluid exchange operations.
And when configured with a laser module, the platform can also be used for retinal photocoagulation and laser trabeculoplasty.
And how does this Adaptive Fluidics advanced update factor in?
The technology is used within the Stellaris Elite system to maintain intraocular pressure (IOP) stability during surgery via automatic, real-time fluid pressure adjustments.
How it works: Via a graphical user integrated (GUI)-integrated toggle control that displays both target and compensated infusion pressures.
- The intent: Versatility, essentially, giving surgeons the ability to activate, deactivate, or customize settings for their preferred levels of surgery phases.
- In other words: Precise and responsive control is ensured during the procedure.
See here for a closer look at this functionality.
And all together?
Adaptive Fluidic integrated with the Bi-Blade+ dual-port vitrectomy cutter are designed to offer a stable, efficient, and high-speed vitreous removal—with minimal IOP fluctuation.
Any data supporting the integration?
Check out this comparison between surgeons using (and not using) Adaptive Fluidics during surgeries involving a Bi-Blade vitrectomy cutter.
And according to surgical case data presented during the Association for Research in Vision and Ophthalmology (ARVO) annual meeting, use of the Bi-Blade+ with Adaptive Fluidics:
- Led to a “notable 62% reduction in average pressure,” versus surgeons not utilizing the technology.
- Resulted in a “significant improvement in chamber IOP,” with a range “closer to physiologic IOP (10-20 mmHg),” even during high vacuum levels.”
So where can I learn more about each of these technologies?
Click here for a look at their product brochures (which include warnings, precautions, and instructions for use).
And how can I learn more about commercial availability for my practice?
Click here to find and contact your local B+L representative.
