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Anterior Cervical

The neck, or cervical spine, consists of seven vertebrae (C1-C7). Common pathologies in the anterior (front) cervical spine include, but are not limited to, disc herniation, stenosis, and cervical disc degeneration. Surgical treatment for these pathologies may include anterior cervical discectomy and fusion (ACDF), and cervical disc replacement. The ACDF procedure generally consists of resecting soft-tissue or bone to decompress nerves roots or the spinal cord, followed by stabilization so that long-term healing can occur. In conjunction with spinal decompression, the use of anterior cervical plates, such as the NuVasive® Helix and Gradient Plus® Anterior Cervical Plate systems, and standalone cervical interbody fixation devices, such as the CoRoent® Small Interlock™ system, provide stability and fixation for varying patient anatomies.  An alternative procedure to an ACDF is a cervical disc replacement surgery, which aims to stabilize the spine while still allowing motion to occur at the joint instead of fusing the vertebrae together. For that reason, artificial cervical disc replacement devices such as the PCM® Cervical Disc have been developed.

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Anterior Cervical

ACDF

A surgical procedure, performed through the front of the neck, to treat spinal cord or nerve root compression by removing the disc, then stabilizing and fusing one or more vertebrae together into a solid section of bone.

Neuromonitoring

  • NVM5®

    Full neurological monitoring EMG/MEP/SSEP and status assessment during spine procedures

    View Indications for Use

    The NVM5® System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon, to help assess a patient’s neurophysiologic status. NVM5® provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial motor evoked potential (TceMEP) or somatosensory evoked potential (SSEP) responses of nerves.

    1. XLIF® (Detection) – The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool.
    2. Basic & Dynamic Screw Test – The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws.
    3. Free Run EMG – The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.
    4. Twitch Test (Train of Four) – The Twitch Test Function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.
    5. TcMEP – Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract. The TcMEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.
    6. SSEP – The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk.
    7. Remote Reader – The Remote Reader function provides real time remote access to the NVM5 System for a monitoring physician outside of the operating room.
    8. The Guidance function is intended as an aid for use in either open or percutaneous pedicle cannulation procedures in the lumbar spine of adult patients, and when used in conjunction with radiographic imaging and EMG, allows the surgeon to assess the angulation of system accessories relative to patient spinal anatomy for the creation of a cannulation trajectory for bone screw placement.
  • ET Tube

    EMG endotracheal tube

    View Indications for Use

    The NVM5/JJB EMG Endotracheal Tube is intended for use with any compatible monitoring system during surgical procedures for continuous EMG neurological monitoring and status assessment of the nerves supplying the laryngeal musculature as well as for providing an open airway for patient ventilation.

Interbody

  • CoRoent®

    System of implants

    View Indications for Use

    The CoRoent® S platforms are intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (DDD) at one level from levels C2-C3 to C7- T1. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment. The System is intended to be used with supplemental fixation and autogenous bone graft only to facilitate the fusion.

    Other members of the NuVasive CoRoent System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon’s discretion.

Interfixated Device

  • CoRoent® Small Interlock™

    Standalone ACDF system

    View Indications for Use

    The CoRoent® Small Interlock System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CoRoent Small Interlock System. The CoRoent Small Interlock System is intended for use with autograft.

Allograft

  • Cancellous Core

    Machined bone allograft

    View Indications for Use

    This allograft may be used in a variety of orthopedic, neurosurgical, reconstructive or periodontal bone grafting procedures.

  • Triad® CR, CC

    Machined bone allograft

    View Indications for Use

    This allograft may be used in a variety of orthopedic, neurosurgical, reconstructive or periodontal bone grafting procedures.

Biologics

  • Osteocel® Plus

    Advanced cellular bone matrix

    View Indications for Use

    This product is restricted to homologous use for the repair, replacement or reconstruction of musculoskeletal defects.

Fixation

  • NuVasive® Helix ACP™

    Traditional anterior cervical plate system

    View Indications for Use

    The NuVasive® HELIX Anterior Cervical Plating System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudoarthosis or failed previous fusion.

  • NuVasive® Helix-Revolution ACP™

    Traditional anterior cervical plate system

    View Indications for Use

    The NuVasive® HELIX Revolution Anterior Cervical Plating System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudoarthrosis or failed previous fusion.

  • NuVasive® Helix-T ACP™

    Translational anterior cervical plate system

    View Indications for Use

    The NuVasive® HELIX Anterior Cervical Plating System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudoarthosis or failed previous fusion.

  • NuVasive® Helix Mini ACP™

    Mini anterior cervical plate system

    View Indications for Use

    The NuVasive® HELIX Mini Anterior Cervical Plating System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudoarthosis or failed previous fusion.

  • Gradient Plus®

    Traditional anterior cervical plate system

    View Indications for Use

    The NuVasive SmartPlate Gradient Plus® System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include:

    1. Degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies
    2. Spondylolisthesis
    3. Trauma
    4. Spinal stenosis
    5. Deformity
    6. Tumor
    7. Pseudarthrosis
    8. Failed previous fusion

Cervical Disc Replacement

A surgical procedure, performed through the front of the neck, to treat spinal cord or nerve root compression by removing and replacing the degenerated disc. Instead of fusing the vertebrae together (ACDF), a cervical disc replacement aims to stabilize the spine while still allowing motion to occur at the affected level. The PCM Cervical Disc is designed to allow patients to preserve all aspects of motion at the level of surgery, including flexion-extension (nodding up or down), lateral bending (side-to-side bending), and axial rotation (turning your neck).

Neuromonitoring

  • NVM5®

    Full neurological monitoring EMG/MEP/SSEP and status assessment during spine procedures

    View Indications for Use

    The NVM5® System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon, to help assess a patient’s neurophysiologic status. NVM5® provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial motor evoked potential (TceMEP) or somatosensory evoked potential (SSEP) responses of nerves.

    1. XLIF® (Detection) – The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool.
    2. Basic & Dynamic Screw Test – The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws.
    3. Free Run EMG – The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.
    4. Twitch Test (Train of Four) – The Twitch Test Function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.
    5. TcMEP – Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract. The TcMEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.
    6. SSEP – The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk.
    7. Remote Reader – The Remote Reader function provides real time remote access to the NVM5 System for a monitoring physician outside of the operating room.
    8. The Guidance function is intended as an aid for use in either open or percutaneous pedicle cannulation procedures in the lumbar spine of adult patients, and when used in conjunction with radiographic imaging and EMG, allows the surgeon to assess the angulation of system accessories relative to patient spinal anatomy for the creation of a cannulation trajectory for bone screw placement.
  • ET Tube

    EMG endotracheal tube

    View Indications for Use

    The NVM5/JJB EMG Endotracheal Tube is intended for use with any compatible monitoring system during surgical procedures for continuous EMG neurological monitoring and status assessment of the nerves supplying the laryngeal musculature as well as for providing an open airway for patient ventilation.

Motion Preservation

  • PCM Cervical Disc

    Anatomically constrained motion preservation

    Device Description

    IDE Clinical Results & Meta-Analysis of the Literature

    View Indications for Use

    The PCM® Cervical Disc is designed to replace the degenerated disc, providing support for the vertebrae while allowing for movement of the joint. The PCM Cervical Disc is a two-piece articulating device comprised of two cobalt chromium molybdenum (CoCrMo) alloy metal endplates, one superior and one inferior, and an ultra-high molecular weight polyethylene (UHMWPE) spacer fixed to the inferior endplate. The articulation consists of a superior concave polished metallic surface and the inferior polyethylene convex surface. The contact between the UHMWPE spacer and the superior component is an unconstrained ball-and-socket articulation.  The bone-contacting surface of each of the endplates has a coating that is comprised of two layers of titanium covered by an electrochemically applied layer of calcium phosphate (BONIT®). This surface has transverse ridges designed to enhance postoperative biologic fixation. In addition, there are two rows of small “teeth” on the bone-contacting surface of each of the endplates that are angled toward each other in a “V” configuration.

    The PCM® Cervical Disc is indicated for use in skeletally mature 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 (CT, MRI, x-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The PCM Cervical Disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment prior to implantation of the PCM Cervical Disc.

    U.S. Clinical Study Information

    The PCM® Cervical Disc was studied in a prospective, multicenter, randomized FDA-approved investigational device exemption (IDE) clinical trial conducted in the United States to evaluate longitudinal outcomes over 2 years comparatively between the PCM Cervical Disc and anterior cervical discectomy and fusion (ACDF) with allograft and plate.  A total of 416 patients with a degenerated cervical disc at one level from C3-C4 to C7-T1 were enrolled in the clinical trial and 403 were treated.  Patients were randomly assigned to be treated either with the PCM Cervical Disc or ACDF.

    Patients were evaluated before surgery, during the operation, immediately after surgery, and then at 6 weeks, 3 months, 6 months, 12 months and 24 months, and yearly after surgery.  The patients were recommended to have a physical therapy program for non-impact exercises and active range of motion exercises after surgery.  Patients were also instructed to avoid repetitive cervical flexion and extension bending and lateral bending and rotation for 6 weeks following surgery.

    The safety of the PCM Cervical Disc was assessed by comparing the adverse events, any additional surgical procedures, and the neurological outcomes to those in the ACDF control group.  The effectiveness of the PCM Cervical Disc was assessed by evaluating patients’ pain and function outcomes using a standard questionnaire, the Neck Disability Index (NDI), the severity of neck and arm pain based on a Visual Analog Scale (VAS) assessment, quality of life using a standard questionnaire, the Short Form-36 (SF-36), as well as a patient satisfaction questionnaire compared to the ACDF control group.

    In addition, the patients were evaluated using radiographic evaluations, including spinal range of motion, spinal disc height, device displacement or migration, spinal fusion status, and heterotopic ossification (abnormal bone formation).

    In the study, the average patient age was 45-years-old and 52% of the patients were men.  Before surgery, approximately 80% of patients had symptoms of radiculopathy (a pathologic condition of the nerve roots) and approximately 19% had both radiculopathy and myelopathy (a disease or disorder of the spinal cord) symptoms.

    The primary endpoint of the IDE trial was a composite measure termed “overall success,” which was evaluated at 24 months postoperatively, and was defined as at least 20% improvement in neck disability index (NDI) from preoperative score; absence of reoperation, revision, or removal; maintenance or improvement in neurological status; and absence of radiographic or major complications during the 24-month follow-up period.  At the 24 months, overall success was achieved by 75.1% of the PCM patients compared to 64.9% of the ACDF patients.

    In the U.S. clinical study of 214 patients who received the PCM Cervical Disc, the most commonly reported device or surgery related adverse events included neck and arm pain 2.3% (5 patients), incision site complications 5.6% (12 patients), dysphagia/dysphonia 5.1% (11 patients), and implant loosening or dislodgement 2.3% (5 patients). In addition, 6.0% (13 patients) required removal of the PCM device and 1.4% (3 patients) required reoperations. There may be other risks associated with using the PCM Cervical Disc. Of the 190 patients that were treated with ACDF, the most commonly reported device or surgery related adverse events included neck/arm pain 16.8% (32 patients), adjacent level disease 14.2% (27 patients), dysphagia/dysphonia 12.1% (23 patients), nonunion 5.8% (11 patients), and neurologic 5.3% (10 patients). Although many of the major risks are listed in this patient information webpage, more comprehensive safety information is provided in the physician’s package insert for the product. Please ask your doctor for more information and an explanation of these risks.

    Complete information will be available in the PCM PMA Summary of Safety and Effectiveness Data (P100012) at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm327487.htm?source=govdelivery.

    Other Clinical Resources

    The growing body of evidence supports the fact that in well-selected patients, cervical arthroplasty is at least as successful (defined in several clinically meaningful ways) as the “gold standard” treatment of ACDF and may indeed offer advantages.  Historic FDA-approved randomized, multicenter IDE clinical trials comparing cervical arthroplasty to ACDF were designed as non-inferiority clinical trials.  These trials, conducted with the goal of FDA product approval, used more stringent success criteria than the historical ACDF studies and yet each individually showed at least non-inferiority of cervical arthroplasty compared with fusion.  However, individually, the trials were not statistically powered to demonstrate a statistically significant improvement in clinical outcomes or “superiority” of one procedure over the other.  A recently published paper using a meta-analysis was performed to pool the data from four approved cervical arthroplasty devices, including the PCM Cervical Disc, in an attempt to improve the statistical strength of the analysis.¹  The results of this meta-analysis suggest that for the common indications studied (1-level cervical disc degeneration with radiculopathy and/or myelopathy), cervical arthroplasty is not statistically different from ACDF in NDI success (15-point improvement from baseline) but is statistically superior to ACDF in the overall success (a composite risk-benefit endpoint), neurological success (maintenance of improvement neurological status from baseline) and survivorship (absence of revisions) outcomes 24 months postoperatively.

    1. McAfee PC, Reah C, Gilder K, Eisermann L, Cunningham B. A Meta-Analysis of Comparative Outcomes Following Cervical Arthroplasty or Anterior Cervical Fusion: Results From 4 Prospective Multicenter Randomized Clinical Trials and Up to 1226 Patients.  Spine;2012, 37:943-952.

    Read the full, published meta-analysis paper in Spine by clicking below.

    http://journals.lww.com/spinejournal/Abstract/2012/05150/A_Meta_Analysis_of_Comparative_Outcomes_Following.7.aspx

Note: References to specific products as components of a surgical procedure/approach do not imply that such products have FDA regulatory clearance or approval for all of the pathologies or indications described. The surgical procedures described on this website may not require the use of some or all of the NuVasive products found on this website. Please refer to the professional product labeling of the NuVasive products for their specific FDA cleared or approved indications of use.



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