NuVasive has announced that the first patient in the United States has been treated with the PCM cervical disc following its approval from FDA, according to a news release.
NuVasive received FDA approval for the device in October. The PCM cervical disc consists of two metal endplates and a plastic insert that fits between the endplates. The device is placed between two adjacent vertebrae to replace a diseased cervical disc that is causing arm pain and/or weakness or numbness.
Paul Sawin, MD, performed the first PCM surgery on a patient in Orlando, Fla.
"We are very pleased with the initial surgeon interest in this innovative technology," said Alex Lukianov, chairman and CEO of NuVasive, in the release. "The first U.S. training courses at the NuVasive East and West coast-based facilities are solidly booked. The unique nature of the PCM cervical disc and the healthy demand for surgeon training gives us confidence in our expectation for $3.5 million to $5 million in related revenue in 2013. The device is a differentiated, game changing solution for the cervical spine, and marks NuVasive's foray into an exciting, rapidly growing market."
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