Simplify Medical completed the Pre-Market Approval (PMA) submission for the 2-level Simplify Disc Investigational Device Exemption Study to FDA. The Simplify Disc is designed for MRI compatibility, physiologic motion and anatomical height-matching, to improve patient outcomes and expand treatment options for patients.
The prospective, multi-center clinical trial enrolled a total of 200 patients at 18 clinical sites across the United States, with enrollment completed in 2018. Simplify was used for 2-level cervical implantation between C3 to C7 vertebrae, and compared with historical fusion control.
"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.”
In September, the Simplify Disc received FDA approval for 1-level Simplify Disc PMA.