BELKIN Vision has received 510(k) clearance from the FDA for the Eagle device, a glaucoma laser intended for use in performing selective laser trabeculoplasty (SLT).
First, a company refresh, please.
Established in 2013, BELKIN Vision is an Israeli medical device company with the sole focus on developing and bringing to market a first-line glaucoma laser treatment.
Now this laser.
The Eagle is a Q-switched, 532 nm-wavelength, frequency-doubled, neodymium-doped yttrium aluminum garnet (Nd:YAG) laser device designed to provide an automated and non-invasive solution for eyecare professionals (ECPs) to offer their glaucoma patients.
To note, the laser is already available for sale in the European Union (EU) and the United Kingdom (UK).
What makes it unique?
The device is the first and—currently only—direct SLT (DSLT) laser for glaucoma that delivers the laser energy through a non-contact approach via the cornea with a more rapid and simplified technique compared to standard SLT.
It includes three main capabilities:
- Precision
- Offers 120 automated treatments (enabled by SureTrac) that are delivered directly to the trabecular meshwork.
- Efficiency
- Complete with an ergonomic patient- and ECP-friendly set up for a streamlined positioning and treatment
- Automation
- Provides simple navigational guidance with an intuitive touch screen
How does it work?
Laser energy is delivered (contactless, of course) directly through the limbus to the trabecular meshwork—all without the use of a gonioscopy lens.
The Eagle “automatically defines the target location then applies the laser treatment sequence while the eye tracker compensates for any eye movement,” according to the company.
And the overall goal of this?
BELKIN intends to provide a user-friendly DSLT technology for ECPs to perform and expand access to early laser therapy for a larger number of glaucoma patients.
Let’s talk laser specs.
Per BELKIN:
- Laser energy range: 0.3 – 2.6 mJ
- Pulse duration: 3 ns
- Spot size: 400 μm
- Laser frequency: 50 Hz with automated approval
- Aiming/ranging beams:
- CW diode laser; 635, 650 nm; 150 μW maximum
- Center for Devices and Radiological Health (CDRH) Classification / International Electrotechnical Commission (IEC) 60825 Classification – I/Class 1
- CW diode laser; 635, 650 nm; 150 μW maximum
- Treatment beam:
- CDRH Classification /IEC 60825 Classification – IIIB/Class 3B
Any clinical data to support it?
Yes actually!
A 2023 study published in the British Journal of Ophthalmology evaluated the efficacy of DSLT (Eagle) against standard SLT in reducing intraocular pressure (IOP) in 201 patients (ages 40+) with open-angle glaucoma (OAG) over a 12-month period..
See here for details on the GLAUrious study (NCT03750201) via Clinical Trials.
Lastly … where can I find it?
Click here to contact BELKIN on future product purchase details.