AxioMed is progressing toward FDA approval for its viscoelastic for lumbar and cervical disc replacement, the devicemaker said April 19.
Four things to know:
1. AxioMed's disc is different from the current ball and socket design and is composed of a proprietary silica-based viscoelastic material, according to a news release.
2. The company plans to submit the final documents for its FDA approval application by June.
3. The company has seen strong results in clinical trials, and more than 800 of AxioMed's discs have been implanted worldwide, according to the release.
4. AxioMed's disc is the only viscoelastic disc replacement to complete a U.S. investigational device exemption trial.