SAN DIEGO, CA–(Marketwire – Dec 20, 2012) – NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, 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.”
About the PCM Cervical Disc
The PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space and manifested by at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The device is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment prior to implantation.
The PCM Cervical Disc is composed of cobalt chrome endplates and a central polyethylene core, materials that have a long and well-studied history of use in other orthopedic joint replacements. The broad radius of the polyethylene core allows for unconstrained motion preservation and a broad radius of articulation for coupled motion. The device features a wide footprint to take advantage of the most stable portions of patients’ cervical vertebral bodies and offers three different footprint and height options. The superior and inferior endplates also feature three rows of “V-Teeth” which provide short-term fixation until long-term biologic fixation can occur to anchor our motion preserving device.