New World Medical receives 510k clearance for device for reduction of IOP in patients with POAG

(Image Credit: AdobeStock/Csaba Deli)

New World Medical announced the FDA has given a 510(k) indication expansion for Kahook Dual Blade (KDB) Glide device to be used for the reduction of IOP in adult patients with primary open-angle glaucoma (POAG) during cataract surgery or as a standalone procedure.

According to a news release from the company, the FDA’s decision was based on data that supports the device’s safety and efficacy in reducing IOP in patients with POAG. With over 100 published studies, including Level-I randomized controlled trial (RCT) data and 5-year published data, KDB GLIDE has been shown to reduce IOP by ≥20% on average.

“This expanded clearance from the FDA acknowledges and validates the patient outcomes that ophthalmic surgeons have been seeing since the launch of this product,” Raymond Kong, New World Medical’s chief commercial officer, said in the release.

Excisional goniotomy is a long-established procedure in which a segment of the diseased trabecular meshwork is removed, which facilitates the flow of aqueous into collector channels of the eye, thus alleviating intraocular pressure. Because goniotomy is appropriate for mild, moderate and severe glaucoma, as a stand-alone procedure or in combination with cataract surgery, more than 4.5 million glaucoma patients in the US alone are suitable candidates.^1,2

As a stand-alone procedure or in combination with cataract surgery, excision of TM tissue facilitates flow of aqueous into the collector channels and episcleral venous system, thereby reducing IOP. The device is designed to excise TM tissue during goniotomy procedures.

The device’s proprietary ramp facilitates the lift and stretch of the TM, which prepares the tissue for excision by the dual blades and increases immediate access to the collector channels. With this indication expansion, surgeons now have a versatile solution to address the complex needs of glaucoma patients, offering enhanced efficacy and procedural flexibility.^3,4

“I have been using KDB since its inception and have experienced great results for my patients when I want to make a difference in their glaucoma control. This expanded indication gives me greater confidence in my choice for my patients and in ensuring a stronger reimbursement pathway,” Nathan Radcliffe, MD, cataract and glaucoma surgeon at New York Ophthalmology and an associate professor of Ophthalmology at Icahn School of Medicine at Mount Sinai, in New York, said in the news release.

Malik Y. Kahook, MD, inventor of KDB and New World Medical’s chief medical advisor, said the company has been focused from day one on making KDB one of the most studied surgical devices in the field of glaucoma.

“Our extensive peer-reviewed publications, including Level I RCT data, have resulted in the momentous occasion of expanding the label of KDB GLIDE,” Kahook said in the news release. “Treating glaucoma through excisional goniotomy with KDB has now entered a new era, and I feel like we are just getting started."

References:

1. Market Scope. 2017 Survey of US Glaucoma Specialists. Q1-2017.
   2. Zhao1 Y, Chen J, Yu X, et al. Age-Related Changes in Human Schlemm's Canal: An in Vivo Optical Coherence Tomography-Based Study. Front. Physiol. 2018 Jun 5;9:630.

2. American Academy of Ophthalmic Executives® Fact Sheet: Goniotomy; January 12, 2023; https://www.aao.org/Assets/c1c5ad6a-f611-4c41-988c-991514f68602/637896975656770000/goniotomy-fs-pdf?inline=1.

3. Ammar DA, Seibold LK, Kahook MY. Preclinical Investigation of Goniotomy Using Four Different Techniques. Clin Ophthalmol. 2020;14:3519-3525
   https://doi.org/10.2147/OPTH.S281811

4. Ammar DA, Porteous E, Kahook MY. Preclinical Investigation of Ab Interno Goniotomy Using Three Different Techniques. Clin Ophthalmol. 2023;17:2619-2623
   https://doi.org/10.2147/OPTH.S424977