Simplify Medical completed its Premarket Approval (PMA) submission for the 1-level Simplify® cervical disc Investigational Device Exemption (IDE) study to FDA. The device is designed for MRI compatibility, physiologic motion and anatomical height-matching, and presents an alternative to fusion.
The prospective, multi-center trial enrolled 166 patients at 16 U.S. sites, and was used for 1-level cervical implantation between C3 to C7 vertebrae and compared with historical fusion control.
The disc is also being evaluated in a separate IDE trial in the U.S. for 2-level procedures.
The Simplify Disc is CE Marked and commercially available in select European markets. Internationally, early market feedback has shown substantial improvement in patient pain scores and functional improvement after treatment.
David Hovda, President and CEO of Simplify Medical, said, "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.”