Sunnyvale, California-based Simplify Medical, Inc. has announced the completion of the Premarket Approval (PMA) application for the company’s Simplify Disc for single level procedures. The cervical artificial disc is composed of a semi-constrained ceramic core sandwiched between PEEK endplates. The endplates are coated with a porous titanium applied via plasma spray. The device is fully compatible with diagnostic MRI due to the use of non-metallic components reducing the need for excess radiation exposure required for CT scans.
Simplify Medical Submits PMA Application for Simplify Disc
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The device was approved for investigational device exemption (IDE) trials for 1- and 2-level use in March and October 2015, respectively. The trials completed enrollment in 2018 and early clinical results of the single-level trial were published in the Journal of Spine and Neurosurgery in 2019. The study reported statistically significant improvements in Neck Disability Index (NDI) and visual analogue scale (VAS) pain scores compared with historic controls for anterior cervical discectomy and fusion (ACDF). The Simplify Disc is CE marked and available in select European markets.
Co-Principal investigators, Dr. Richard Guyer and Dr. Domagoj Coric, both said that they are excited about this important milestone. Dr. Guyer continued by saying, “This cervical disc offers the benefits of a replacement that is anatomic in design, mimics the motion of a normal healthy disc and allows for distortion free MR imaging. I believe this technological advancement is going to improve clinical outcomes for patients undergoing treatment for cervical disc disease.”
The most recently approved cervical disc replacement is the Orthofix M6-C, originally from Spinal Kinetics. The M6-C was approved in February 2019, approximately 15 months after the PMA application was filed.
Simplify Medical President and CEO David Hovda, expressed his gratitude to everyone involved in the trial, “The submission of our 1-level PMA study is the culmination of hard work and years of data collection. I’d like to thank all of our dedicated surgeon investigators and their teams who have participated in the trial. We are very proud to have completed this pivotal milestone in the FDA approval process.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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