17 Dec Simplify Medical Announces First Implantation of its Cervical Artificial Disc in the U.S. Following 1-Level Approval from the FDA
SUNNYVALE, Calif., Dec. 16, 2020 (GLOBE NEWSWIRE) — Simplify Medical, Inc., a privately-held company focused on cervical spinal disc arthroplasty and developer of the Simplify® Cervical Artificial Disc, today announced its first surgery following the recent FDA approval for 1-level use. 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. The Simplify Disc achieved superiority to the fusion control on the trial’s composite primary endpoint (93.0% vs. 73.6%).
The first Simplify Cervical Artificial Disc commercial procedure was performed at the Texas Back Institute (TBI) in Plano, TX on a thirty-two-year-old man from the Dallas-Fort Worth area, by Dr. Richard Guyer, along with Dr. Scott Blumenthal and Dr. Jack Zigler, founders of the Center for Disc Replacement at TBI.
“I am honored to perform the first cervical total disc replacement procedure using the Simplify Disc post-FDA approval. The patient is doing very well after this procedure. We are pleased to offer this advanced cervical disc replacement to our patients as a potential alternative to fusion. The Simplify Disc offers unique benefits of lower height discs, as well as 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 Richard Guyer, MD, Chairman of the Texas Back Research Institute Foundation
David Hovda, President and CEO of Simplify Medical, said, “As a co-Primary Investigator in our 1- and 2-level clinical trials, we are excited Dr. Guyer performed the first procedure following our PMA approval. Having this surgery performed at TBI is a fitting recognition of his efforts. In addition, the tremendous support of co-Primary Investigator Domagoj Coric, MD, Chief, Department of Neurosurgery at Carolinas Medical Center, as well as the support from all of our dedicated surgeon investigators, their teams and the patients who participated in the trial, was essential to achieving this milestone.”
Mr. Hovda continued, “We believe Simplify Disc sets a new standard for clinical success in treating cervical radiculopathy in our clinical study, and we are excited to provide an option for patients that achieved superiority to fusion for a 1-level indication. We plan a controlled, targeted commercial launch with an extensive training and education program to support the best possible outcomes for our patients.”
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, Inc. 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/.
*MR Conditional per ASTM F2503
CAUTION: Simplify Disc is limited to investigational use for 2-level indication.
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LifeSci Advisors, LLC