Hot on the heels of the announcement that it had gained CE mark approval in February, Simplify Medical, Inc. has now gained U.S. FDA Investigational Device Exemption (IDE) approval to initiate its clinical trial comparing Simplify Disc with anterior cervical discectomy and fusion (ACDF) as a control.
Simplify Medical is pioneering disc arthroplasty with the non-metal, MRI friendly Simplify Cervical Artificial Disc. Simplify Disc is a cervical disc replacement composed of the a combination of PEEK and ceramic MRI friendly materials, which means this diagnostic modality can be used in preference to more invasive CT scans. This means reduced radiation exposure, while providing a metal-free option to patients.
The Simplify IDE Trial is a prospective, multi-center, core lab adjudicated clinical trial evaluating the Simplify Disc at up to 10 U.S. sites.
David Hovda, CEO of Simplify Medical, said, “We have worked collaboratively with the FDA to achieve IDE approval, and we look forward to starting our study later this year. We are excited to move forward with the Simplify Disc, which demonstrated promising clinical performance in an OUS clinical trial and commercial settings.”
Source: PR Newswire