NuVasive Inc. (NSDQ:NUVA) said the FDA granted pre-market approval for its PCM cervical disc implant, sending NUVA shares up more than 2% on Wall Street today.
The San Diego-based medical device company said the implant is designed to preserve motion in the cervical spine, in lieu of a standard fusion procedure. The FDA nod came after a 403-patient investigation device exemption trial, according to NuVasive.
NUVA shares were trading at $14.23 as of about 12:30 p.m. today, up 2.3%.
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"We are really pleased to offer this unique technology to the U.S. surgical and patient community. The PCM cervical disc is a game-changing solution for the cervical spine, and marks our foray into an exciting market," chairman & CEO Alex Lukianov said in prepared remarks. "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."
The PCM device is indicated for single-level reconstruction of degenerated cervical discs from the C3-C4 to C6-C7 vertebrae after discectomy, according to a press release.
