Simplify Medical concluded enrollment for its U.S. investigational device exemption trial testing the Simplify cervical artificial disc.
Here are five insights:
1. The company capped enrollment at 166 patients at 16 sites across the country.
2. The trial is assessing the Simplify Disc for one-level cervical implantation between C3-C7.
3. Domagoj Coric, MD, of Charlotte-based Carolina Neurosurgery and Spine Associates, and Richard Guyer, MD, of Plano-based Texas Back Institute Foundation, are serving as national co-primary investigators.
4. The Simplify Disc is made mostly of PEEK-on-ceramic, allowing its visibility on MRI.
5. The Simplify Disc already has the CE Mark.