Simplify Medical Completes PMA Submission for 2-Level Simplify Disc IDE Study
Builds on recent 1-Level PMA Approval
SUNNYVALE, Calif., Oct. 29, 2020 (GLOBE NEWSWIRE) -- 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.
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.
CAUTION: Simplify Disc is limited to investigational use for 2-level indication.