Zimmer Biomet Spine Announces FDA Approval of Mobi-C Cervical Disc Labeling Extension

Zimmer Biomet Holdings Inc., a global leader in musculoskeletal healthcare, announced the U.S. Food and Drug Administration (FDA) has approved an extension to the Mobi-C Cervical Disc labeling to include seven-year clinical results. The updated data remain consistent with the previous findings at two and five years, namely, that at seven years of follow-up, Mobi-C is statistically non-inferior in terms of overall study success for one-level use and is statistically superior in terms of overall study success for two-level use when compared to anterior cervical discectomy and fusion (ACDF). The Mobi-C Cervical Disc is a leading option for cervical total disc replacement (cTDR) that is designed to maintain patient range of motion post-surgery.
 
This FDA labeling update follows the recent publication of the seven-year follow-up data in the January 2018 issue of the peer-reviewed International Journal of Spine Surgery, the official scientific journal of the International Society for the Advancement of Spine Surgery (ISASS), as well as multiple podium presentations of the seven-year follow-up data at the International Society for the Advancement of Spine Surgery (ISASS) Annual Meeting in April 2018 and the North American Spine Society (NASS) Annual Meeting in October 2017.
 
The prospective, randomized clinical trial compared cTDR with Mobi-C to ACDF and followed almost 600 patients through seven years. The study showed that cTDR with Mobi-C was associated with nominally lower pain scores, maintained range of motion, less adjacent level degeneration and adjacent level subsequent surgery, as well as a lower rate of secondary surgery compared to ACDF.
 
“The seven-year results hold immense validation for Mobi-C, demonstrating clinical superiority—considering efficacy, safety, and repeat surgeries— of two-level cervical total disc replacement compared to ACDF,” said Rebecca Whitney, general manager of Zimmer Biomet’s Spine division. “With multiple podium presentations at top industry conferences educating the medical community on the key data, publication of the full data set in a leading spine journal, and now the FDA’s approval of our label extension to include these significant findings out to seven years, we are well-positioned to continue the growth and expanded adoption of Mobi-C with orthopedic and neurosurgeons to treat even more patients indicated for cervical total disc replacement who desire maintained range of motion post-surgery.” 

Mobi-C is the first cervical disc prosthesis approved by the FDA for reconstruction of a cervical disc at both one and two levels (C3-C7). Mobi-C is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis that is inserted in a single step, without requiring bone chiseling to accommodate vertebral anchorage such as screws or keels. The Mobi-C Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or neurological deficit) with or without neck pain or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (computed tomography, magnetic resonance imaging, or X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes) and/or visible loss of disc height compared to adjacent levels. The Mobi-C Cervical Disc Prosthesis is implanted using an anterior approach. Patients should have failed at least six weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment prior to implantation of the Mobi-C Cervical Disc Prosthesis.
 
Founded in 1927 and headquartered in Warsaw, Ind., Zimmer Biomet designs, manufactures, and markets orthopedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products. The company’s products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Zimmer Biomet has operations in more than 25 countries around the world and sell products in more than 100 countries.