New World Medical Receives 510(k) Clearance for KDB GLIDE Expanded Indication for Reduction of IOP
New World Medical has announced it has received FDA 510(k) clearance for KDB (Kahook Dual Blade) GLIDE 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.
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. With recent increased scrutiny around reimbursement for minimally invasive glaucoma surgery (MIGS) procedures, this validation from the FDA is a significant step for New World Medical, the ophthalmology space, and most importantly the patients who benefit from our products,” Raymond Kong, Chief Commercial Officer, New World Medical, said in a company news release.
The KDB GLIDE is a surgical tool designed to precisely excise trabecular meshwork (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. According to New World Medical, with this indication expansion, surgeons now have a versatile solution to address the complex needs of glaucoma patients, offering enhanced efficacy and procedural flexibility.[1,2]
"We have 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,” said Malik Y. Kahook, MD, inventor of KDB and New World Medical Chief Medical Advisor. “Treating glaucoma through excisional goniotomy with KDB has now entered a new era, and I feel like we are just getting started."
References
- 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 - 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