Zimmer Biomet Spine has announced that over 150,000 Mobi-C Cervical Discs have been implanted worldwide. The implant, a cobalt chromium alloy and polyethylene mobile-bearing prosthesis, was first implanted in France in 2004 and was approved for sale in the U.S. by the FDA in 2013.
Noting the bulwark of data on the device, James Cloar, President of Zimmer Biomet Spine, states, “Mobi-C is supported with great, long-term clinical data and we are proud to announce this milestone that highlights its market success, as well.”
“The availability of the Mobi-C artificial disc has helped surgeons give patients the best opportunity to maintain motion and avoid a fusion. This leads to faster return to work and lower rates of adjacent level disease,” adds Dr. Michael Hisey, board-certified orthopedic surgeon at Texas Back Institute who was a participant in the Investigational Device Exemption study. “With the Mobi-C one step insertion and mobile core technology, I have a disc that allows me to operate with a familiar technique and I know that the disc motion will adapt to patients with a variety of cervical conditions.”
According to Zimmer Biomet Spine, “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 or other 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 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.”
Jim Cloar told OTW, “Reaching this significant patient milestone aligns with our clinical and commercial confidence in the Mobi-C device. As other cervical discs enter the market, it is important for surgeons to know, not just the clinically proven statistical superiority of two-level Mobi-C over two-level anterior cervical discectomy and fusion (ACDF), but also the impressive number of cases performed that represents growing surgeon acceptance of cervical disc arthroplasty as a procedure and specifically the Mobi-C as a best-in-class device.”
“One anticipated effect of the coronavirus epidemic is the shifting of elective surgical procedures from hospitals to ambulatory surgery centers (ASCs). Cervical disc arthroplasty with Mobi-C is a procedure that is well-suited to the ASC environment. So while concern over the spread of the virus may reduce the volume of more complex spinal fusion cases (to treat spinal deformity, for example) that must be done in a hospital O.R. setting, we hope that Mobi-C cases could still be performed with regularity by surgeons with access to ASCs.”
