Talk about saving the best for last. During the penultimate day, Oct. 26, of the nearly weeklong annual meeting of the North American Spine Society, San Diego, Calif.-based NuVasive Inc. revealed that the U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) for the company’s PCM cervical disc system.
Company officials say the device is a motion preservation option in the cervical spine instead of a traditional, motion-eliminating fusion procedure. The FDA approval follows the completion of a prospective, multicenter randomized investigational device exemption (IDE) clinical trial that was conducted at 23 investigational sites across the United States and included 403 total treated patients.
The PCM device is composed of cobalt chrome endplates and a central polyethylene core. The broad radius of the polyethylene core allows for unconstrained motion preservation and a broad radius of articulation for coupled motion, company officials noted. The device has a wide footprint in order to capitalize on the most stable portions of patients' cervical vertebral bodies. It offers three footprint and height options. The superior and inferior endplates also feature three rows of "V-Teeth," which provide short-term fixation until long-term fixation can occur to anchor the device.
Alex Lukianov, chairman and CEO called the device a “game-changing solution” for the cervical spine, and is the beginning of a new market for the company.
“This device has many design considerations that make it a truly unique product offering compared to other cervical motion preserving devices,” Lukianov said. “Its low-profile design enables it to be minimally disruptive to the adjacent anatomy and a viable treatment option for levels adjacent to prior fusions."
According to Laetitia Cousin, vice president of Regulatory and Clinical Affairs at NuVasive, the strong clinical data “speaks for itself” and called the effort to reach the PMA “monumental.”
She added: “Our investigators have contributed over 17 peer-reviewed publications on the PCM cervical disc in internationally recognized journals. I
am exceptionally proud of the surgeons, clinical research staff, patients, and dedicated NuVasive shareowners that contributed to the advancement of science through the IDE trial and helped to bring this device to market."
The PCM implant is indicated for skeletally mature (adult) 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: 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 six weeks of conservative treatment prior to implantation.
In the long term, the device could mean stronger sales for NuVasive, according to Leerink Swann analyst Richard Newitter. While he doesn’t expect the device to generate material revenue before early to mid-2013, “more color” about the company’s launch strategy should develop during the next few weeks following investor meetings.
“We will wait to adjust our estimates pending additional guidance at these investor events,” he said, adding that his current sales projections for NuVasive do not “bake in” any revenue contribution from the new device.
“The disc launches should represent a source of upside to both our NUVA (NuVasive’s stock market ticker symbol) 2013 projections,” Newitter said. “We estimate that every approximate 3 to 5 percent penetration of the approximately $200 million worldwide cervical disc market reflects roughly $6 million to $10 million in incremental sales.”