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.”
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.
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.”
You are out of free articles for this month
Subscribe as a Guest for $0 and unlock a total of 5 articles per month.
You are out of five articles for this month
Subscribe as an Executive Member for access to unlimited articles, THE
ORTHOPAEDIC INDUSTRY ANNUAL REPORT and more.
Our site uses cookies to allow easier access for Members and subscribers and to improve our site. You agree to our use of cookies by closing this message box or continuing to use our site.OkRead more
Copy to clipboard 
