Product Overview

The Mobi-C® Cervical Disc (Mobi-C) 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 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.

An Investigational Device Exemption (IDE) study of Mobi-C for both one and
two-level cervical intervertebral disc replacement has been completed in the United States. 

Mobi-C is the first cervical disc FDA approved for one and two-level indications.

For more detailed information about Mobi-C, click here to go to www.cervicaldisc.com


Product Features

Materials:

  • Three-piece design with two Cobalt Chromium alloy endplates (CoCrMo) and an Ultra High Molecular Weight polyethylene core (UHMWPE)
  • The endplates are Titanium plasma sprayed and coated with hydroxyapatite for bony on-growth

Patented Mobile Bearing Technology:

  • Controlled mobility is provided with a mobile core that can slide and turn up to 1mm on the inferior endplate
  • Designed to facilitate both independent and coupled motions similar to natural cervical spine motion

Bone Sparing Technology:

  • No bone chiseling, no invasive keels or screws required 
  • Intact bony endplates provide a preserved surface that is ideal for
    two-level implantation
  • Intraoperative flexibility to optimize implant positioning

Ease of Insertion:

  • Mobi-C provides one step insertion, with no additional exposure or operative steps required for keel or screw placement
  • Mobi-C comes preassembled on a disposable radiolucent PEEK cartridge

Clinical Results

LDR conducted an Investigational Device Exemption (IDE) clinical trial involving 599 patients comparing Mobi-C Cervical Disc to Anterior Discectomy and Fusion (ACDF) at one and two contiguous levels. Mobi-C is the only cervical disc FDA approved for one and two-level indications.

Click here to view the full Mobi-C Clinical Results on www.cervicaldisc.com

Study Design:

The Mobi-C IDE trial was multi-centered, prospective, randomized and controlled. The trial tested Mobi-C for non-inferiority to the current standard of care, 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.

  • Investigational treatment: anterior discectomy followed by insertion of Mobi-C at one-level or two contiguous levels
  • Control treatment: anterior discectomy followed by insertion of allograft bone and an anterior cervical plate (DePuy Spine Slim-Loc® or the Medtronic Atlantis® or Atlantis Vision®
  • Randomization scheme: 2 to 1 ratio, Mobi-C to ACDF respectively
  • 599 total patients involved (both one and two-level patients)
  • The trial allowed for 1 non-randomized training case per site and resulted in 15 non-randomized subjects in the one-level arm, and 9 non-randomized subjects in the two-level arm
  • 24 investigative sites
  • Post-operative follow-up: 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months

Two-level Study Arm Highlights:

In the two-level arm of the IDE trial, Mobi-C demonstrated superiority in overall trial success compared to ACDF, which is a standard option for treating degenerative disc disease. Findings comparing Mobi-C to ACDF in the two-level arm at the 24 month endpoint included:

  • Mobi-C implanted at two-levels demonstrated superiority in overall trial success compared to ACDF. The difference between Mobi-C’s overall success rate of 69.7% and ACDF’s rate of 37.4% is statistically superior (p<0.0001).
  • The rate of secondary surgery at the index levels for Mobi-C was 3.1% versus 11.4% for ACDF.
  • Mean return to work time was 45.9 days for Mobi-C compared to 66.8 days for ACDF.

The percentage of subjects who reported negative radiographic changes from baseline in adjacent segments was:

  • 2.9% of Mobi-C patients compared to 18.1% of ACDF patients at the inferior adjacent level; and
  • 13.1% of Mobi-C patients compared to 33.3% of ACDF patients at the superior adjacent level.

This clinical trial established that Mobi-C at two contiguous levels is statistically superior to ACDF at 24 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.


One-level Study Arm Highlights:

In the one-level arm of the IDE trial, Mobi-C demonstrated non-inferiority in overall trial success compared to ACDF, which is a standard option for treating degenerative disc disease. Findings comparing Mobi-C to ACDF in the one-level arm at the 24 month endpoint included:
  • Mobi-C implanted at one-level demonstrated non-inferiority in overall trial success compared to ACDF. The difference between Mobi-C’s overall success rate of 73.7% and ACDF’s rate of 65.3% represented statistical non-inferiority (p=0.0021). 
  • The rate of secondary surgery at the index level for Mobi-C was 1.2% versus 6.2% for ACDF.
  • Mean return to work time was 29.3 days for Mobi-C compared to 36.8 days for ACDF.
The percentage of subjects who reported negative radiographic changes from baseline in adjacent segments was:
  • 7.7% of Mobi-C patients compared to 21.0% of ACDF patients at the inferior adjacent level; and
  • 14.6% of Mobi-C patients compared to 25.0% of ACDF patients at the superior adjacent level.
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 information about the Mobi-C clinical trial results, click here to go to www.cervicaldisc.com

LDR offers Mobi-C electronic press kits for surgeon customers, hospitals, or other health care providers interested in obtaining media coverage for Mobi-C in their local markets.  This kit is intended only for certified Mobi-C surgeons or facilities associated with those surgeons.

General contents of the Mobi-C press kit includes:  product images, video short clips, fact sheets, and other drafting tools. 

To submit a request for a Mobi-C press kit, click the link below to complete the required information.  Your request will be sent to the Mobi-C Marketing Group for consideration.

Click Here to enter a request for the Mobi-C press kit

For more info, please visit CervicalDisc.com

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.

Note: Please refer to the Mobi-C Summary of Safety and Effectiveness Data (PMA P110002 & P110009) at www.fda.gov for complete study results.

For more detailed information about Mobi-C, click here to go to www.cervicaldisc.com


To report problems or a planned removal of Mobi-C, or for further questions, please CLICK HERE.  

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