Surgeons treated the first patient in the investigational device exemption clinical trial testing Sunnyvale, Calif.-based Simplify Medical's Simplify cervical artificial spinal disc.
Here are six takeaways:
1. The disc, composed of non-metal materials, is intended to treat cervical degenerative disc disease at two adjacent levels.
2. Surgeons may view the disc on MRI without artifact interference, saving patients from potential radiation from CT scans.
3. John Peloza, MD, of Plano-based Texas Back Institute, implanted the disc.
4. The study will include 215 patients at up to 15 centers, with researchers comparing implantation of two contiguous discs from C3 to C7 during two-level cervical fusion.
5. Domagoj Coric, MD, Charlotte, N.C.-based Carolinas Medical Center's neurosurgery department chief, and Richard Guyer, MD, chairman of the Texas Back Institute Foundation, serve as the national co-principal investigators.
6. The Simplify Disc earned the CE Mark, and has been used to treat more than 600 patients outside the United States in the last three years.