The U.S. Food and Drug Administration (FDA) has granted an expanded indication for KDB GLIDE® to reduce intraocular pressure (IOP) in adults with primary open-angle glaucoma during cataract surgery or as a standalone procedure, New World Medical, the manufacturer of the device, has reported.
The decision was based on safety and efficacy data, including a level-1 randomized, controlled trial and 5-year data. KDB GLIDE has been shown to reduce IOP by an average of 20% or more.
“With recent increased scrutiny around reimbursement for minimally invasive glaucoma surgery 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, Chief Commercial Officer of New World Medical, in a press release.
KDB GLIDE is a surgical tool used to excise trabecular meshwork tissue. With this indication, it is now the only goniotomy device indicated for the excision of trabecular meshwork tissue to reduce IOP in adult patients with primary open-angle glaucoma during cataract surgery or as a stand-alone procedure.
Reference
New World Medical receives 510k clearance for KDB GLIDE® expanded indication, enhancing glaucoma treatment options. New World Medical press release. May 22, 2024. Accessed May 22, 2024. https://www.newworldmedical.com/new-world-medical-receives-510k-clearance-for-kdb-glide-expanded-indication-enhancing-glaucoma-treatment-options/
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