Dymicron Secures US FDA IDE Approval for Triadyme-C Cervical Disc Study
Shots:
- Dymicron received the US FDA’s IDE approval to initiate a pivotal trial of Triadyme-C, a cervical artificial disc, to treat symptomatic cervical disc disease (SCDD) across leading US spine centers starting Q4’25
- The study will compare the safety and effectiveness of Triadyme-C vs. anterior cervical discectomy and fusion (ACDF). The 1EP of the study is defined as NDI score improvement, neurostatus maintenance, and no secondary surgeries
- Triadyme-C features Adymite, a proprietary polycrystalline diamond material engineered to minimize wear debris and replicate spinal motion via tri-lobed design
Ref: PRNewswire | Image: Dymicron| Press Release
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