SUNNYVALE, Calif., Sept. 21, 2020 (GLOBE NEWSWIRE) -- 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 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.
About Simplify® Disc
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. 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.
About Simplify Medical
Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to optimize diagnostic imaging and decrease the need for ionizing radiation. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.
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