The US Food and Drug Administration recently expanded its 510(k) clearance for KDB Glide (New World Medical), making it the only goniotomy device indicated for the excision of trabecular meshwork (TM) to reduce intraocular pressure (IOP) in adult patients with primary open-angle glaucoma. The KDB Glide can be used either during cataract surgery or as a stand-alone microinvasive glaucoma surgery (MIGS) procedure.

Goniotomy is an established procedure; by opening the TM, flow of aqueous into the collector channels and episcleral venous system is facilitated, reducing IOP. According to New World Medical’s chief medical advisor, Malik Y. Kahook, MD, KDB Glide is among the most studied surgical devices in the field of glaucoma, with over 100 published studies. Analysis of level 1 randomized controlled trial (RCT) data and 5-year published data show that goniotomy with KDB Glide reduces IOP by ≥20% on average, said Dr. Kahook. 

Devices cleared by the FDA through the 510(k) process are eligible for reimbursement from the Centers for Medicare and Medicaid Services (CMS).

“This expanded clearance from the FDA acknowledges and validates the patient outcomes that ophthalmic surgeons have been seeing since the launch of this product,” said Raymond Kong, New World Medical’s chief commercial officer, in a press release. “With recent increased scrutiny around reimbursement for minimally invasive glaucoma surgery (MIGS) procedures, this validation from the FDA is a significant step.”