NuVasive®, Inc.

NuVasive® Announces First Patient in the United States Treated with the PCM® Cervical Disc Following FDA Approval

SAN DIEGO – On December 20, 2012, NuVasive® announced that Paul Sawin, M.D., performed the first PCM Cervical Disc surgery on a patient in Orlando, Florida, today. Surgeon proctors, who will instruct upcoming training courses, have started scheduling surgeries now that the new device is available. Surgeon demand for training is strong with courses scheduled to begin next month. 

NuVasive received FDA approval for the PCM Cervical Disc in October 2012 after successful completion of a prospective, multicenter randomized investigational device exemption (IDE) clinical trial.  The novel device is now being provided to patients and surgeons in the United States as an innovative option to preserve motion in the cervical spine instead of a traditional, motion-eliminating fusion procedure.

Alex Lukianov, Chairman and CEO of NuVasive, said “We are very pleased with the initial surgeon interest in this innovative technology.  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.”

For the complete press release please click here:

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