This article is more than 5 years old. Information may no longer be current.
FDA approves cervical disc system
Click Here to Manage Email Alerts
NuVasive Inc. announced that the FDA has granted premarket approval for the PCM Cervical Disc System.
According to a company press release, the device preserves motion in the cervical spine instead of a traditional, motion-eliminating fusion procedure. The approval comes after the completion of a prospective, multicenter randomized investigational device exemption clinical trial that was conducted at 23 investigational sites across the United States and included 403 total treated patients.
“This device has many design considerations that make it a truly unique product offering compared to other cervical motion preserving devices. Its low-profile design enables it to be minimally disruptive to the adjacent anatomy and a viable treatment option for levels adjacent to prior fusions,” Alex Lukianov, chairman and chief executive officer of NuVasive, stated in the release.