BVI Medical has received 510(k) clearance from the FDA for its next-generation laser endoscopy ophthalmic system, dubbed “Leos.”
First, let’s get a BVI rundown.
Operating since 1932, the Walham, Massachusetts-headquartered medical equipment manufacturer specializes in the surgical ophthalmic space.
Its product portfolio— geared toward cataract, glaucoma, and vitreoretinal (among other ophthalmic) procedures—is available across 90 countries and includes:
- Equipment
- Take a look at the Endo Optiks, BVI’s first endoscopic cyclophotocoagulation (ECP) system
- Medical devices and instruments
- Intraocular lenses (IOLs)
- Surgical fluids
Before we get to this system, I need a refresher on endoscopy.
In ophthalmology: An ocular endoscopy refers to a medical procedure in which a thin and flexible tube-like instrument with an attached camera and light on one end is used for visualizing the interior structure of the eye to diagnose and treat anterior segment diseases relating to:
- Ciliary body
- Angle of anterior chamber
- Posterior iris epithelium
- IOL position
- Capsular support
Notably: Each of these are otherwise too difficult to access and visualize with a standard microscope.
Most commonly: This ophthalmic procedure is used for endoscopic cyclophotocoagulation (ECP).
Talk about ECP.
Not to be confused with photocoagulation for retinal surgery, this form of minimally-invasive glaucoma surgery (MIGS) utilizes a laser to target the ciliary body—the site of aqueous humor production, where most of the eye’s fluid is made—as well as lower IOP and reduce (or even eliminate) the need for glaucoma medications.
How the laser comes into play: A surgeon will deliver a controlled laser application to directly visualize the ciliary processes—avoiding the need for implants and the potential for device-related complications (as used in traditional cyclophotocoagulation [CPC]).
- Another advantage: This “direct” visualization of the ciliary body also limits damage to the underlying ciliary body and surrounding tissue.
Got it. Next up: Leos.
The glaucoma surgical system is designed to provide “a more intuitive laser ECP [endoscopic cyclophotocoagulation] procedure” that integrates into the surgical workflow.
- Its claim to fame: That aforementioned laser-based component.
BVI credits Leos as “the only laser system that lowers intraocular pressure [IOP] by addressing aqueous humor production in a minimally invasive ab interno procedure.”
And how does it do this?
Via endoscopic skills that present glaucoma surgeons with an enhanced visualization of the eye’s anatomy not offered in older or current imaging systems, according to the company.
So who are the target patients?
Leos is reported to target those with early-stage glaucoma as well as a wide spectrum of glaucoma types.
Any supporting clinical data to know about?
BVI shared that the system’s safety and efficacy are validated by “emerging data” from a randomized clinical trial.
That study: Published in Ophthalmology Glaucoma in 2023, the CONCEPT trial evaluated 160 patients diagnosed with primary open-angle glaucoma (POAG) and cataracts (with half receiving ECP with cataract surgery and the other half undergoing cataract surgery alone).
- The purpose: To determine the extent and duration of ECP’s IOP-lowering effects versus phacoemulsification alone (with washout IOP as the primary outcome)
- The findings: ECP demonstrated a greater reduction in mean and median IOP.
A research note: The 1-year data from this study will be reported by Kin Sheng LIM, MD, during next week’s annual American Society of Cataract and Refractive Surgeons (ASCRS) meeting in Los Angeles, California.
- That presentation: Saturday, April 26 (see here for details).
And how has ECP performed in prior clinical research?
Previous research has noted success rates for ECP in anterior and posterior approaches ranging from 90% to 78% in adults and 54% to 34% in pediatric patients.
- In the long-term, however: A 2024 study also reported a success rate of 65.3% among glaucoma patients (following 1+ ECP procedure) after 5 years of follow-up—with influential factors such as age of onset, follow-up length, extent of ECP treatment, and disease severity.
Noted. So where can I see Leos for myself?
BVI is planning for an official product launch during the 2025 American Academy of Ophthalmology (AAO) annual meeting later this year (Oct. 18-20 in Orlando, Florida).
So, in a nutshell: Commercialization is expected in 2025.