FDA Gives 510(k) Clearance to NeuraMedica’s DuraFuse Dural Clips

The FDA has given 510(k) clearance to NeuraMedica’s DuraFuse Dural Clips.

The bioabsorbable clips are intended to close incidental and planned spinal durotomies in less time than it takes to suture the dura traditionally, the company said. The dura is the tough outermost membrane enveloping the brain and spinal cord.

The clips are an improvement on metallic clips, which are permanent and can cause imaging artifacts.

Dural Clips, said the company, are intended to address the issue of repairing the dura mater as quickly as possible when opened to prevent cerebrospinal fluid leakage.

The company plans a commercial launch of the clips later this year.