Simplify Cervical Artificial Disc, which features the lowest available disc heights, starting at 4mm, is designed to fit patient anatomy, protect facets, and prevent overstuffing. At 24 months, there was a significant decrease in pain, significant increase in function, and increased motion from pre-operative levels when compared to ACDF. Simplify Disc is the only CTDR to be able to demonstrate lack of progression of facet degeneration through 24 months.
Simplify Cervical Artificial Disc has a three-piece design with two endplates and a semi-constrained mobile core. This design permits 12° flexion/extension, lateral bending, and axial rotation. The unique articulation, which allows variable center of rotation, was designed to restore motion.
Simplify Cervical Artificial Disc's PEEK endplates and ceramic core permit detailed anatomic visualization on MR imaging.* In addition to being surgeons’ preferred imaging method for the spine, MRI spares patients radiation exposure.
*MR Conditional per ASTM F2503
Simplify Cervical Artificial Disc is composed of two PEEK endplates, coated with titanium plasma spray and a ceramic core. There is no nickel or any metal on the articulating surfaces, which minimizes metal-wear debris. This material combination was chosen with the goal of optimizing biocompatibility for a lifetime implant.
Simplify Cervical Artificial Disc's three-piece design is available in 12 size combinations to fit a broad range of patient anatomies. The domed superior endplate was designed to fit into the natural concavity of vertebral bodies and has a retention ring to prevent core expulsion. The teeth on the superior endplate and the fin on the inferior plate are designed to ensure vertebral fixation.
Simplify Disc was approved for 1-level use in September 2020, and achieved superiority to fusion with an overall success rate of 93.0%. Simplify Disc achieved superiority in percentage of patients with a 15-point Neck Disability Index (NDI) improvement and patients with no neurological deterioration. Simplify Disc patients had no device failures.
Simplify Disc achieved superiority: 97.9% of Simplify Disc patients achieved a significantly higher rate of meaningful (15-point) improvement in NDI compared to ACDF (fusion) patients at 88%.
Simplify Disc demonstrated superiority: 99.6% of Simplify Disc patients had no neurological deterioration compared to 94.1% of ACDF (fusion) patients.
Simplify patients had no device failures.
Simplify Disc mean NDI improved from 63.3 at baseline to 13.6 at 24 months. The difference in percentage points between groups was statistically significant at all follow-up timepoints, in favor of the Simplify Disc group (p<0.05).
Simplify Disc Patients had less adjacent level degeneration compared to ACDF (fusion) patients:
Review and download Simplify Cervical Artificial Disc literature, including Instructions for Use, Surgical Technique Guide, and Patient Labeling.