New NuVasive Cervical Implant Inserted Successfully
San Diego, Calif.-based spine company NuVasive’s PCM cervical disc has been successfully implanted into a patient for the first time. Paul Sawin, M.D., performed the procedure on Dec. 20 in Orlando, Fla., according to the company. Sawin is a neurosurgeon trained in complex spinal surgery.
NuVasive received U.S. Food and Drug Administration approval for the PCM cervical disc in October last year after successful completion of a prospective, multicenter randomized investigational device exemption clinical trial. The device is an option to preserve motion in the cervical spine instead of a traditional, motion-eliminating fusion procedure. Now that the device is available, surgeon proctors—who will instruct upcoming training courses—have started scheduling surgeries. According to NuVasive, surgeon demand for training is strong with courses scheduled to begin this month.
“We are very pleased with the initial surgeon interest in this innovative technology,” said Alex Lukianov, chairman and CEO of NuVasive. “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.”