Rare FDA Approval for Simplify Cervical Disc

Simplify Medical, Inc.’s artificial cervical disc, the Simplify^® Disc, now has FDA premarket application (PMA) approval. Unlike FDA 510(k) clearances which only have to demonstrate substantial equivalence to a previously approved device, rare PMA approvals require a demonstration of safety and effectiveness.

Superior to Fusion

A September 21, 2020 announcement from the Sunnyvale, California-based company, stated the approval was for 1-level indications and was based on the device achieving superiority to fusion on the composite primary endpoint.

Company CEO and President David Hovda said the Simplify study was the first cervical disc replacement study to incorporate MR imaging at 24 months, “allowing the FDA to review this compelling data which contributed to a strong benefit-risk profile.”

Prospective Trial With Guyer and Coric

The company’s prospective trial, with Drs. Richard Guyer and Domagoj Coric, as co-principal investigators, enrolled 166 patients at 16 clinical sites in the U.S. Results were compared with a historical fusion control. Enrollment was completed in February 2018. A two-year follow-up was completed in March 2020. The company then submitted a PMA to the FDA. The FDA granted approval within six months.

Guyer is chairman of the Texas Back Research Institute Foundation and Coric is chief of the department of neurosurgery at Carolinas Medical Center.

For the trial, the disc was used for 1-level cervical implantation between the C3 to C7 vertebrae.

Study Results

Here, according to the company, here are the study results “…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).
• 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 Device

Guyer said the device “offers the benefits of an anatomic design that provides excellent motion and allows for virtually distortion free MR imaging. I believe this state-of-the-art disc replacement will improve clinical outcomes for patients undergoing treatment for cervical disc disease.”

Coric said the “next-generation” disc has “unique biomaterials which offers real clinical advantages for our patients and supported by solid trial data.”

The disc is a motion-preserving cervical artificial disc. The company says it is “designed to allow for advanced imaging capability of MRI, to better match patients’ anatomies, and for physiologic movement. It is composed of advanced, primarily non-metal materials (PEEK-on-ceramic) to permit the full diagnostic imaging capability of MRI, potentially minimizing patient exposure to ionizing radiation. 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.”

The disc is also being evaluated in a separate IDE (investigational device exemption) study in the U.S. for 2-level indications. The enrollment for that trial was completed in November 2018. The disc is limited to investigational use for this indication.

Simplify is CE Marked in Europe and commercially available in select European markets.