New World Medical’s received 510k indication expansion from the FDA for KDB (Kahook Dual Blade) Glide, expanding its use for reduction of IOP in adult patients with primary open-angle glaucoma either during cataract surgery or as a standalone procedure. The KDB Glide is designed to precisely excise trabecular meshwork tissue during goniotomy procedures, the maker says. 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, the FDA’s grant of an expanded indication was based on more than 100 published studies supporting the instrument’s safety and efficacy, as well as 5-year published data.