New World Medical, Inc. announced that its Kahook Dual Blade (KDB) GLIDE has received a 501(k) expanded indication from the FDA for a new procedure.
Give me a refresher on this company.
Founded in 1990 and based in Cucamonga, California, NWM was founded by current President and CEO Abdul Mateen Ahmed, PhD, as a manufacturer of ophthalmic devices.
The company’s flagship products include:
- Ahmed Glaucoma Valve
- Glaucoma drainage device designed for immediate intraocular pressure (IOP) reduction for all types of refractory glaucoma
- Ahmed ClearPath
- Valve-less glaucoma drainage device that doesn’t need a valve to open/close based on IOP
- STREAMLINE Surgical System
- Implant-free procedure with single-use device for cataract surgery
- KDB GLIDE (our topic of discussion)
Now let’s discuss this device.
Originally registered with the FDA in October 2020, the KDB Glide became commercially available for advanced excisional goniotomy in order to enable precise excision of disease trabecular meshwork (TM).
The procedure: Includes a surgeon using a special mirrored lens to insert the KDB Glide and make parallel incision (using dual blades) within the trabecular meshwork (TM), essentially unroofing it and opening up Schlemm’s Canal’s inner wall to improve aqueous humor outflow from the eye.
The intended result: IOP reduction.
And what is this expanded indication for?
The KDB Glide is now indicated to be used to reduce IOP in primary open-angle glaucoma (POAG) patients during cataract surgery or a standalone procedure.
So what led to this?
Per NWM, this latest indication was established based on new extended data from 100+ studies that supported the surgical tool’s ability to reduce IOP in POAG patients.
These studies included “Level-1 randomized controlled trial (RCT) data and 5-year published data,” the company noted.
Those findings: The KDB Glide reduced IOP by an average of ≥20%
Give me more on this research.
The Level-1 RCT referenced was a 2020 study published in Clinical Ophthalmology that evaluated the tissue-level effects of four different goniotomy techniques—including the KDB Glide—on the TM.
The techniques included:
- Microvitreoretinal (MVR) blade
- 360° trabeculotomy with 5-0 prolene suture
- KDB Glide
- TrabEx device (MicroSurgical Technology)
Note: Each tissue sample from these devices underwent a standard histologic processing with hematoxylin and eosin (H&E) staining (which identifies different cell and tissue types and helps to diagnose diseases) and then comparative analyses.
And a more detailed look at those findings …
Out of the four techniques, only the KDB Blade and TrabEx device performed excisional goniotomy, with the blade producing “an excisional opening in TM of consistent width along its entire length and did so without obvious damage to neighboring structures,” according to the study authors.
Key differences between the two devices:
- First: The KDB Blade features a non-cutting ramp that elevates, stretches, and guides TM to two parallel blades before any parallel incisions in the TM are developed.
- Comparatively: The TrabEx device features two parallel serrated blades that extend to the device’s tip, leading to TM tissue being cut after the device tip’s insertion into the canal (without the tissue being elevated and stretched).
- Comparatively: The TrabEx device features two parallel serrated blades that extend to the device’s tip, leading to TM tissue being cut after the device tip’s insertion into the canal (without the tissue being elevated and stretched).
- Second: The KDB Blade features a footplate designed to allow for proper fit and stability during the procedure, which the authors noted likely leads to a more uniform treatment of tissue.
- Comparatively: The TrabEx device has no distinct footplate that would allow for the device to be evenly positioned on the Schlemm’s canal’s interior wall while still advancing toward treatment.
And the results of these differences?
Because of these distinct differences, the authors concluded that the TrabEx device’s techniques “appear to lead to inconsistent excision of TM tissue along its path.”
Thus: Only the KDB Glide was found to result in reliable excision of TM.
See here for similar findings from a 2023 study evaluating three ab interno goniotomy techniques on human TM.
Nice! So what’s the overall significance of the FDA’s clearance?
Aside from offering adult glaucoma patients an expanded alternative for reducing their IOP, NWM’s Chief Commercial Officer Raymond Kong noted that it’s a major validation for the company and ophthalmology space as whole—particularly in light of recent increased scrutiny surrounding reimbursement for minimally-invasive glaucoma surgery (MIGS) procedures.
“Treating glaucoma through excisional goniotomy with KDB has now entered a new era, and I feel like we are just getting started,” stated Malik Y. Kahook, MD, NWM chief medical advisor (and inventor of the KDB Blade).