Simplify Medical Inc. has received approval from the Food and Drug Administration to start a clinical trial of its Simplify Disc, a non-metal, cervical artificial disc as a treatment for cervical disc disease.
The FDA granted an Investigational Device Exemption for the two-level trial, which will compare the Simplify Disc to anterior cervical discectomy and fusion as a control, the company announced in a news release last week.
The trial is a prospective study evaluating the Simplify Disc at up to 14 clinical sites in the U.S. and Australia.
The Simplify Disc is a cervical artifici...
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