Several cervical artificial disc technologies have been developed to replace degenerated intervertebral discs in the cervical spine. While no artificial disc can perfectly replace a natural disc’s ability to cushion and transfer loads in the neck, an artificial disc may maintain more of the cervical spine’s natural range of motion compared to fusion surgery.

Artificial discs are available in various sizes, shapes, and heights in order to achieve these goals and provide good surgical outcomes. Several types of discs have been fabricated using different materials, designs, and techniques.

And now a California company has just obtained FDA approval for another promising product.

Simplify® Disc is a motion-preserving cervical artificial disc designed to allow for advanced imaging capability of MRI, to better match patients’ anatomies, and for physiologic movement. The three-piece disc, with a semi-constrained mobile core, is designed to mimic/replicate the natural biomechanical motion of a healthy disc. Implantation of the Simplify Disc is accomplished in a straightforward, three-step procedure.

Simplify Medical, a privately-held company, headquartered in Sunnyvale California, focused on cervical spinal disc arthroplasty and developer of the Simplify® cervical artificial disc, announced U.S. Food and Drug Administration (FDA) Approval for the Simplify Disc Pre-Market Application (PMA) for 1-level indications. Simplify Disc achieved superiority to the fusion control on the composite primary endpoint.

The prospective trial enrolled 166 Simplify Disc patients at 16 clinical sites across the United States, and results were compared with a historical fusion control. Simplify Disc was used for 1-level cervical implantation between the C3 to C7 vertebrae.

The study results demonstrated that Simplify Disc achieved superiority in overall success compared to anterior cervical discectomy and fusion (ACDF). At 24 months:

— The Simplify Disc overall success rate of 93.0% was statistically superior to the ACDF overall success rate of 73.6% (p<.001).
— 97.9% of Simplify Disc patients achieved a significantly higher rate of meaningful (15 point) improvement in Neck Disability Index (NDI) compared to ACDF at 88.0% (p=.009).
— Simplify Disc mean NDI improved from 63.3 at baseline to 13.6 at 24 months, and was superior to ACDF at all follow-up timepoints.
— Simplify Disc patients had a higher rate of improvement in neurological function at 79.9% compared to ACDF at 54.7%.
— Simplify Disc mean VAS (Neck/Arm Pain) of 15.6 was superior to ACDF at 23.3 (p<.001).
— Significantly fewer Simplify Disc patients, 10.8%, were taking narcotic pain medication compared to ACDF patients at 36.8% (p<.001).
— Time to recovery (defined as 15 points of NDI improvement) was faster for Simplify Disc patients compared to ACDF patients. At 6 weeks, 87.0% of Simplify Disc patients and 76.8% of ACDF patients had achieved this threshold. At 3 months, 95.9% of Simplify Disc patients and 81.1% of ACDF patients had achieved recovery.
— Simplify Disc patients had less adjacent level degeneration compared to ACDF patients. At the disc level above the treatment level, 82% of Simplify Disc patients and 52% of ACDF patients had no progression in degeneration. At the disc level below the treatment level, 72% of Simplify Disc patients and 34% of ACDF patients had no progression in degeneration.

The Simplify Disc is also being evaluated in a separate IDE study in the U.S. for 2-level indications. The enrollment for the 2-level trial was completed in November 2018. Simplify Disc is limited to investigational use for this indication.