Synergy Spine Solutions

Restoring Balance to Motion Preservation

Approval & IDE Study

FDA PMA Approval

The Synergy Disc is FDA Approved for use in the U.S. for 1-level indications at C3-C7. The Synergy Disc achieved superiority to the fusion control on the primary endpoint of composite clinical success.

FDA approval of the Synergy Disc is supported by clinical evidence generated through a rigorous prospective clinical study conducted under an Investigational Device Exemption (IDE) in the U.S. The company also has over 10 years of clinical experience with the Synergy Disc outside the United States in more than 10 countries, where the device has been commercially available and implanted in thousands of patients.

Indications

The Synergy Disc is indicated in skeletally mature patients for reconstruction of the disc at one level from C3-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 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 Synergy Disc 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 Synergy Disc.

Synergy Disc should not be implanted in patients with the following conditions:

  • Tumor or trauma
  • Intractable radiculopathy or myelopathy necessitating surgical treatment at more than one cervical level
  • Allergy or sensitivity to the implant materials (e.g., titanium and polyethylene)
  • Bridging osteophytes
  • Radiographic instability on lateral, coronal or flexion / extension radiographs: translation greater than 3.5mm and/or greater than 11 degrees greater of angular difference from either adjacent segments
  • Facet joint degeneration
  • Active systemic or local infection
  • Osteoporosis defined as Dual-Energy X-ray Absorptiometry (DEXA) bone mineral density T-score less than -2.5
  • Advanced cervical spine conditions or diseases at the index level other than those included in the Indications for Use (e.g., rheumatoid arthritis, Diffuse Idiopathic Skeletal Hyperostosis (DISH), ankylosing
    spondylitis).

IDE Study Results

The IDE study results demonstrated that the Synergy Disc achieved superiority in composite clinical success compared to
the anterior cervical discectomy and fusion (ACDF) control, with the following results at 24 months:

  • The Synergy Disc primary endpoint of composite clinical success was 87.1%, achieving superiority (p<0.0001) to
    the fusion control.
  • 91.7% of patients in the Synergy Disc group achieved a clinically meaningful improvement on the Neck Disability Index at 2
    years, compared to 75.2% in the fusion group.
  • The mean Neck pain score of 15.6 (0-100 VAS) in the Synergy Disc group was lower than 30.2 in the fusion group.
    Synergy Disc patients had lower worst arm pain scores (15.0) than the fusion group (32.2).
  • Disc angle in the Synergy Disc group increased from 2.6 pre-operatively to 6.5 degrees at 24 months.
  • Overall patient satisfaction was higher in the Synergy Disc group at 84.5% compared to 61.6% in the fusion group.

Clinical Trials with the Synergy Disc

Synergy Spine Solutions® has started a number of clinical research projects to support the Synergy Disc. There is one two trial in progress in the United States and several outside the United States.

Cervical degenerative disc disease (DDD) is a condition characterized by degenerated and/or diseased discs leading to nerve root and/or spinal cord compression in the cervical spine. The treatment continuum spans from conservative treatments and therapies to surgical procedures. While less prevalent than low back pain, cervical DDD is equally debilitating and requires careful clinical management to ensure patients return to a normal quality of life.

The Synergy Disc is a cervical disc prosthesis that can be inserted between C3-C7 in skeletally mature patients after cervical discectomy to provide restoration of motion and alignment to the functional spinal unit. The Synergy Disc is intended for use in the cervical spine for reconstruction of the disc following discectomy for intractable radiculopathy and/or myelopathy.

2-Level US IDE Study. This trial is no longer enrolling patients, however it is a multicenter, non-randomized, historically controlled study designed to show that the Synergy Disc is at least as safe and effective as an Anterior Cervical Discectomy and Fusion (ACDF) procedure to treat a degenerated cervical disc at two levels. All patients in this study received the Synergy Disc and are currently being followed for at least 2 years. https://www.clinicaltrials.gov/study/NCT05740176?term=Synergy%20Disc&rank=7

Contact Us

More information on any of Synergy Spine Solutions’ clinical trials, please email research@synergyspinesolutions.com and we will get back to you promptly with details.