Article
FDA panel supports premarket approval of stent
The FDA ophthalmic devices panel supports the premarket approval of an implant (iStent Trabecular Micro-Bypass Stent Model GTS-100 L/R, Glaukos) for use in conjunction with cataract surgery to reduce IOP in patients with mild-to-moderate, open-angle glaucoma treated with ocular hypotensive medication.
Laguna Hills, CA-The FDA ophthalmic devices panel supports the premarket approval of an implant (iStent Trabecular Micro-Bypass Stent Model GTS-100 L/R, Glaukos) for use in conjunction with cataract surgery to reduce IOP in patients with mild-to-moderate, open-angle glaucoma treated with ocular hypotensive medication.
The panel reviewed data from a 12-month, prospective, randomized, open-label, multicenter, controlled clinical trial conducted at 27 sites in the United States. Members voted 7-1-0 that there is a reasonable assurance that the implant is safe for the indication, voted 6-2-0 that there is a reasonable assurance that the implant is effective for the indication, and voted 7-1-0 that the benefits outweigh the risks of the implant for the indication.
Panel members did express concerns with the overall effectiveness of the implant, noted a lack of effectiveness at 24 months, and recommended that the indication for use reflect the temporary nature of the device’s effectiveness.
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