Simplify Medical has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to initiate its clinical trial comparing Simplify Disc with anterior cervical discectomy and fusion (ACDF) as a control.
The Simplify IDE trial is a prospective, multicentre, core lab adjudicated clinical trial evaluating the Simplify Disc at up to 10 US sites.
Simplify Disc is a cervical disc replacement composed of MRI-friendly materials designed to eliminate invasive computed tomography (CT) scans, reduce ionising radiation exposure, and provide a metal-free option to patients. Simplify Disc offers disc heights as low as 4.2mm for smaller patient anatomy.
IDE approval follows the recent Simplify Disc CE mark. The company also announced it was recently acquired by MH Carnegie, an Australian private equity/venture capital group.