... for 2-Level Simplify Disc IDE Study
SUNNYVALE, Calif., Oct. 29, 2020 - Simplify Medical, Inc., maker of the Simplify® Cervical Artificial Disc, announced today the completion of the Pre-Market Approval (PMA) submission for the 2-level Simplify Disc IDE Study to the U.S. Food and Drug Administration (FDA). The Simplify Disc is designed for MRI compatibility, physiologic motion, and anatomical height-matching, with the goals of improving patient outcomes and expanding treatment options for patients.
"We are excited to be the third company to submit a PMA for a 2-level cervical disc replacement indication, and pleased to submit to FDA shortly after our 1-level PMA approval,” said David Hovda, President and CEO of Simplify Medical. “Our PMA came together due to the outstanding work of our investigators and their clinical colleagues and patients, working in concert with our team every day.”
The prospective, multi-center clinical trial enrolled a total of 200 patients at 18 clinical sites across the United States, with enrollment completed in November 2018. The Simplify Disc was used for 2-level cervical implantation between C3 to C7 vertebrae and compared with historical fusion control.
“This submission marks yet another regulatory achievement for this next generation cervical artificial disc with unique biomaterials,” said Domagoj Coric, MD, Chief of Neurosurgery at Carolinas Medical Center and national Co-Principal Investigator for the study. “I believe this technological advancement is going to improve clinical outcomes for patients undergoing treatment for cervical disc disease.”
Dr. Richard Guyer, chairman of the Texas Back Research Institute Foundation and national Co-Principal Investigator for the study added, “We are excited for this important milestone in the FDA approval process. In addition to the strong clinical evidence produced in the Simplify Disc 1-level trial, this cervical disc offers the benefits of a replacement that is anatomic in design, maintains motion and allows for distortion free MR imaging.”
The Simplify Disc recently received FDA Approval for 1-level Simplify Disc PMA. In this study, Simplify Disc achieved overall success rate of 93.0%, which was superior to the anterior cervical discectomy (ACDF) control group.
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