Superior to fusion for two-level disc replacement.
Mobi-C is an artificial disc, designed to maintain neck motion.
The Mobi-C Cervical Disc has been designed for cervical disc replacement to restore segmental motion and disc height. The components of Mobi-C include superior and inferior cobalt chromium molybdenum alloy endplates coated with plasma sprayed titanium and hydroxyapatite coating, and a polyethylene mobile bearing insert. The controlled mobility of the patented mobile core is the foundation of Mobi-C, encouraging height restoration and respect of the instantaneous axis of rotation for a return to physiological mobility of the spinal segment.
Mobi-C was approved via an Investigational Device Exemption (IDE) clinical trial involving 599 patients comparing Mobi-C to Anterior Cervical Discectomy and Fusion (ACDF) at one and two contiguous levels. Mobi-C is the first cervical disc FDA approved for both one and two-level indications. The U.S. Food and Drug Administration (FDA) approved an update to the Mobi-C labeling to include seven-year clinical results.
The Mobi-C IDE trial was a multi-center, prospective, and randomized controlled trial. The trial tested Mobi-C for non-inferiority to ACDF. The trial planned for the testing of superiority in the event that non-inferiority was established. The primary trial endpoint analysis was based upon 24 month results. The IDE trial consisted of one-level and two-level treatment arms conducted simultaneously under the same FDA approved protocol.
In the two-level arm of the IDE trial, Mobi-C demonstrated superiority in overall trial success compared to ACDF at 84 months. Findings comparing Mobi-C to ACDF in the two-level arm at the 84-month time point included:
This clinical trial established that Mobi-C at two contiguous levels is statistically superior to ACDF at 60 months for overall trial success. Mobi-C is a safe and effective surgical option at two contiguous levels in the cervical spine from C3-C7 for indicated patients.
In the one-level arm of the IDE trial, Mobi-C demonstrated non-inferiority in overall trial success compared to ACDF at 84 months. Findings comparing Mobi-C to ACDF in the one-level arm at the 84 month endpoint included:
Mobi-C is a safe and effective surgical option at one-level in the cervical spine from C3-C7 for indicated patients.
For more detailed Mobi-C clinical trial results, visit cervicaldisc.com/clinical-results.
The Mobi-C® Cervical Disc Prosthesis (Mobi-C®) is a single use device for cervical intervertebral disc replacement at one level or two contiguous levels from C3 to C7 designed to maintain/restore segmental motion and disc height. The components of the Mobi-C® include a cobalt, chromium, molybdenum (CoCrMo per ISO 5832-12) alloy superior spinal plate, an inferior CoCrMo spinal plate, and an ultra-high molecular weight polyethylene (UHMWPE per ISO 5834-2) mobile insert. The inner contact surfaces of the superior and inferior spinal plates are spherical and flat, respectively. This allows for fully congruent contact surfaces between the spinal plates and mobile insert. The two lateral stops of the inferior plate are designed to control and limit the mobility of the mobile insert. The spinal plates, both superior and inferior, feature two rows of teeth which are designed to aid in initial and long term fixation and stability. The teeth are designed to sink into the bone to facilitate endplate fixation and do not require any bone removal or chiseling prior to insertion. A titanium (per ASTM F1580) and hydroxyapatite (per ISO 13779) plasma spray coating is applied to the bony interface surfaces of the superior and inferior spinal plates.
Indications for Use
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 a 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 (CT, MRI, 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 6 weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment prior to implantation of the Mobi-C® Cervical Disc Prosthesis.
The Mobi-C® Cervical Disc Prosthesis should not be implanted in patients with the following conditions:
Mobi-C® should only be used by surgeons who are experienced with anterior cervical spinal procedures and have undergone hands-on training in the use of this device. Only surgeons who are familiar with the implant components, instruments, procedure, clinical applications, biomechanics, adverse events, and risks associated with the Mobi-C® should use this device. A lack of adequate experience and/or training may lead to a higher incidence of adverse events, including neurological complications.
Correct selection of the appropriate implant size is extremely important to assure the placement and function of the device. Information regarding proper implant size selection, implant site preparation, and the use of the instrumentation before, during, and after Mobi-C® surgery is provided in the Mobi-C® Surgical Technique Manual and the Mobi-C® Instrument System Instructions for Use. Users are advised to read and understand the surgical technique manual and instructions for use prior to surgery.
Due to the proximity of vascular and neurological structures to the implantation site, there are risks of serious or fatal hemorrhage and risks of neurological damage with the use of the device. Care must be taken to identify and protect these structures.
Heterotopic Ossification (HO) is a potential complication associated with artificial cervical discs and could lead to reduced cervical motion. However, the presence of HO has not been correlated with adverse clinical outcomes involving the Mobi-C® Cervical Disc Prosthesis in the G050212 clinical trial.
The safety and effectiveness of this device has not been established in patients with the following conditions:
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For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the package insert and information on this website. To obtain a copy of the current Instructions for Use (IFU) for full prescribing and risk information, please call 1-800-348-2759, press 4 for 411 Technical Support.