San Diego medical device company NuVasive Inc. (Nasdaq: NUVA) has announced that Paul Sawin, M.D., performed the first PCM Cervical Disc surgery on a patient in Orlando, Fla.
NuVasive received U.S. Food and Drug Administration approval for the PCM Cervical Disc in October 2012 after successful completion of a prospective, multicenter randomized investigational device exemption clinical trial. The device is now being provided to patients and surgeons in the United States as an option to preserve motion in the cervical spine instead of a traditional, motion-eliminating fusion procedure.
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 in January 2013.
Alex Lukianov, chairman and CEO of NuVasive, said in a statement that the company is pleased with the initial surgeon interest.
"The first U.S. training courses at the NuVasive East and West coast-based facilities are solidly booked," he said. "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.
He called the device a "game-changing solution" for the cervical spine.