Simplify Medical announced completion of enrollment and treatment of all patients in its U.S. Investigational Device Exemption (IDE) pivotal trial of the Simplify® Disc, evaluated for two-level cervical disc replacement.
Comprising PEEK-on-ceramic materials, Simplify—CE Marked and available in select European markets—is designed to be clearly viewed on MRI with minimal artifact, potentially protecting patients from radiation associated with CT scans.
The prospective, multi-center controlled trial enrolled 200 patients at 18 centers. The primary endpoint is the success rate of Simplify in two contiguous levels from C3 to C7, compared with two-level anterior cervical discectomy and fusion.
Simplify Medical announced completion of enrollment and treatment of all patients in its U.S. Investigational Device Exemption (IDE) pivotal trial of the Simplify® Disc, evaluated for two-level cervical disc replacement.
Comprising PEEK-on-ceramic materials, Simplify—CE Marked and available in select European markets—is designed to be clearly...
Simplify Medical announced completion of enrollment and treatment of all patients in its U.S. Investigational Device Exemption (IDE) pivotal trial of the Simplify® Disc, evaluated for two-level cervical disc replacement.
Comprising PEEK-on-ceramic materials, Simplify—CE Marked and available in select European markets—is designed to be clearly viewed on MRI with minimal artifact, potentially protecting patients from radiation associated with CT scans.
The prospective, multi-center controlled trial enrolled 200 patients at 18 centers. The primary endpoint is the success rate of Simplify in two contiguous levels from C3 to C7, compared with two-level anterior cervical discectomy and fusion.
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