The expanded indications make KDB GLIDE the only goniotomy device indicated for the excision of trabecular meshwork tissue (TM) to reduce intraocular pressure (IOP) in adult patients with primary open-angle glaucoma during cataract surgery or as a stand-alone procedure.
New World Medical, a leading innovator in ophthalmic surgical devices, is proud to announce the receipt of 510(k) indication expansion from the U.S. Food and Drug Administration (FDA) 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. This milestone marks a significant advancement in glaucoma treatment, providing expanded options for adult patients.
Proven and reliable
The FDA’s decision was based on extensive 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.” said Raymond Kong, New World Medical, chief commercial officer.
Goniotomy is a well-established MIGS procedure, described by the American Academy of Ophthalmology as an incision or excision of the TM with a blade or other surgical instrument for at least several clock hours to create an opening into Schlemm’s canal from the anterior chamber, via an internal approach through the anterior chamber.1 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.2
The KDB GLIDE is a revolutionary surgical tool designed to precisely 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,” said 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.
Gold standard
The Kahook Dual Blade has set the gold standard as a precise, efficacious, cost-effective solution for excisional goniotomy, and the expanded indication of KDB GLIDE is both a reflection and outgrowth of that well-earned status.
"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."
The expanded indication for KDB GLIDE reaffirms New World Medical's commitment to innovation and excellence in ophthalmic surgery. The company remains dedicated to advancing the field of glaucoma management through groundbreaking technologies and collaborative partnerships with clinicians and researchers worldwide.
References
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.
Glaucoma Surgical Device Report – Market Scope July 2023
Ammar DA, Seibold LK, Kahook MY. Preclinical Investigation of Goniotomy Using Four Different Techniques. Clin Ophthalmol. 2020;14:3519-3525https://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;17:2619-2623https://doi.org/10.2147/OPTH.S424977