Simplify Medical Receives FDA Approval for 1-Level Simplify Disc PMA
Simplify Medical, a privately-held company focused on cervical spinal disc arthroplasty and developer of the Simplify® cervical artificial disc, today 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.
David Hovda, President and CEO of Simplify Medical, said, “We are pleased that FDA, after a thorough review of our PMA, determined that Simplify Disc is safe and effective for 1-level cervical disc replacement in the United States. We are proud to have achieved superiority to fusion on the primary endpoint, and are excited to be 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. On behalf of the Simplify Medical team, I would like to thank our dedicated surgeon investigators, their teams, and the patients who participated in this important trial.”
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. Enrollment was completed in February 2018. The PMA was submitted to FDA after a 24-month follow-up was completed in March of this year. Simplify Disc was used for 1-level cervical implantation between the C3 to C7 vertebrae. The Study Co-Principal Investigators are Richard Guyer, MD, chairman of the Texas Back Research Institute Foundation and Domagoj Coric, MD, Chief, Department of Neurosurgery at Carolinas Medical Center.
“We look forward to offering this advanced cervical disc replacement to our patients as an alternative to fusion. In addition to the strong clinical evidence produced in the Simplify Disc trial, this cervical disc replacement 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,” commented Dr. Guyer.
Dr. Coric added, “I am excited about reaching this important milestone for this next generation cervical artificial disc with unique biomaterials which offers real clinical advantages for our patients and supported by solid trial data.”
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.
The Simplify Disc is CE Marked in Europe and commercially available in select European markets.
See Full Press Release at the Source: Simplify Medical Receives FDA Approval for 1-Level Simplify Disc PMA
Press Release by: Simplify Medical
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