Simplify Medical finished enrolling patients for its investigational device exemption pivotal trial evaluating its Simplify Disc for two-level cervical disc replacement.
Here are five highlights:
1. The cervical disc is designed for biomechanical motion, anatomical height-matching and MRI compatibility to treat degenerative disc disease.
2. Simplify Medical enrolled 200 patients in the study at 18 sites across the U.S.
3. The study will evaluate the rate of the Simplify Disc in two contiguous levels from C3 to C7 compared with two-level anterior cervical discectomy and fusion.
4. The company received CE mark approval in Europe for the Simplify Disc. The device is available in select European markets.
5. Simplify Medical is also conducing a one-level IDE trial for the Simplify Disc. The company completed its enrollment for the study in February.