HEALTHCARE PROVIDERS

Key Benefits

Simplify Disc is the only cervical artificial disc designed to allow the full diagnostic imaging capability of MRI

  • Minimizes patient exposure to high-dose ionizing radiation from CT scans
    • Simplify Disc is composed of PEEK and ceramic composite, so it requires no CT scans
    • Imaging of conventional metallic cervical discs requires CT scans
  • Eliminates need for invasive post-operative CT/Myelograms
    • Simplify Disc can spare patients the potentially harmful side effects of contrast media
      injections into the cerebrospinal fluid
  • Inserts as one pre-assembled unit using a streamlined 3-step procedure
  • Anatomic in design
    • Simplify Disc is available in heights as low as 4mm to treat a broad range of patients
    • Simplify Disc may benefit patients with smaller anatomies for whom currently available
      implant options are not suitable
    • Simplify Disc may expand the number of patients eligible for treatment
  • No metal wear from articulating components
    • Other conventional discs use rigid metal endplates, which can impinge and wear
    • PEEK-on-ceramic composite articulation is designed for low levels of wear, to optimize long-term durability of Simplify Disc

“MRI is considered the ideal screening method for investigation of patients with cervical myelopathy or radiculopathy, and is preferred to CT and myelography due to its high soft tissue contrast discrimination and noninvasiveness.”

– Sundseth J, et al. Eur Spine J 2013.1

 

“The average effective dose in cervical spine CTs is 5.0 mSv, which is the equivalent of 400 chest X-rays.”

– Linet MS, et al. CA Cancer J Clin 2012.2

 

References:

 

    1. Sundseth J, et al. Magnetic resonance imaging evaluation after implantation of a titanium cervical disc prosthesis: a comparison of 1.5 and 3 Tesla magnet strength. Eur Spine J 2013. 22:2296–2302.
    2.  

    3. Linet MS, et al. Cancer Risks Associated
      With External Radiation From Diagnostic Imaging Procedures. CA Cancer J Clin 2012; 62(2):75-100.

 

Simplify Disc features two PEEK endplates articulating on a ceramic composite core.

 

The bone contacting surface of each endplate is coated with biocompatible porous titanium to promote stable bony ongrowth3.

Clinical Data

Simplify Disc is based on a predecessor disc with over 5 years of clinical data demonstrating clinical effectiveness, including:

  • Primary endpoint results showed superiority to cervical fusion (ACDF)
  • Both disc and ACDF control groups experienced a clinically significant NDI
    improvement of ≥15 points at follow-up through 60 months
  • At 60-months 85.2% (69/81) of disc subjects experienced a clinically significant
    NDI improvement of at least 15 points
  • NDI improvement was demonstrated within 6 weeks of implantation with 78.4% reporting at least a 15 point improvement
  • NDI improvement is clinically significant and sustained through 60-month follow up

Please contact us to be added as an invited healthcare provider to obtain updated Simplify Disc clinical data and information.

Surgeon Training

Simplify Medical is commited to working with surgeons through continuing education.
Please contact your local Simplify Medical distributor to learn more about Simplify Disc training programs.

Abstracts & Publications

Outcomes of Single-level Cervical Disc Arthroplasty Versus Anterior Cervical Discectomy and Fusion

Tracey RW*, Kang DG, Cody JP, Wagner SC, Rosner MK, Lehman RA Jr.
Journal of Clinical Neuroscience, June 28, 2014
*Department of Orthopaedic Surgery, Walter Reed National Military Medical Center
http://www.ncbi.nlm.nih.gov/pubmed/24986154

Comparison of the Short- and Long-term Treatment Effect of Cervical Disk Replacement and Anterior Cervical Disk Fusion: a Meta-analysis

A. Muheremu, X. Niu, Z. Qu, Y. Muhanmode, W. Tian.
European Journal of Orthopedic Surgery, May 5, 2014
Department of Orthopedic Oncology Surgery, Beijing Ji Shui Tan Hospital
http://www.ncbi.nlm.nih.gov/pubmed/24791930

Advocacy: ISASS Policy Statement- Cervical Artificial Disc

Domagoj Coric, MD.
Department of Neurosurgery, Carolinas Medical Center, Charlotte, NC
https://www.isass.org/public_policy/2014-04-23-isass-policy-statement-cervical-artificial-disc.html

Cervical total disc replacement is superior to anterior cervical decompression and fusion: a meta-analysis of prospective randomized controlled trials.

Zhang Y., et al., Department of Orthopedic Surgery, Zhejiang, PR China.
PLoS One. 2015 Mar 30;10(3):e0117826.
http://www.ncbi.nlm.nih.gov/pubmed/25822465

Long Term Societal Costs of Anterior Discectomy and Fusion (ACDF) versus Cervical Disc Arthroplasty (CDA) for Treatment of Cervical Radiculopathy.

Ghori A., et al., Int J Spine Surg. 2016 Jan 7;10:1.
Massachusetts General Hospital, Brigham and Women’s Hospital, Boston, MA.
http://www.ncbi.nlm.nih.gov/pubmed/26913221

Assessment of Magnetic Resonance Imaging Artifact Following Cervical Total Disc Arthroplasty.

AH Fayyazi1, J Taormina2,D Svach3, J Stein4, NR Ordway2. Int J Spine Surg. July 14, 2015
1. OAA Orthopaedic Specialists, Allentown, PA.
2. SUNY Upstate Medical University, Syracuse, NY.
3. Research & Testing, Depuy Synthes, West Chester, PA.
4. Clinical Biostatistics & Data Management, DePuy Synthes, West Chester, PA.
http://www.ncbi.nlm.nih.gov/pubmed/26273548

Mid- to Long-Term Outcomes of Cervical Disc Arthroplasty versus Anterior Cervical Discectomy and Fusion for Treatment of Symptomatic Cervical Disc Disease: A Systematic Review and Meta-Analysis of Eight Prospective Randomized Controlled Trials.

Y Hu Y1, G Lv1, S Ren2, D Johansen3. PLoS One. February 12, 2016
1. Department of Spine Surgery, 2nd Xiangya Hospital, Central South University, Changsha, Hunan, P.R. China.
2. Department of Resp Medicine, Second Xiangya Hospital of Central South University, Changsha, Hunan, P.R. China.
3. Orthopaedic Hospital Research Center, David Geffen School of Medicine at UCLA, Los Angeles, California, U.S.
http://www.ncbi.nlm.nih.gov/pubmed/26872258


Case Studies

Case Study 1

Dr. H.H. Relling, Bloemfontein, Free State, South Africa

PATIENT: Middle-aged male with acute radicular pain in the left upper limb for several weeks prior to initial examination.

The patient developed acute radicular pain in the left upper limb two weeks prior to initial examination date. He was treated conservatively with analgesics and anti-inflammatory medication as well as physiotherapy, in which he presented with intense side pain and burning pain in the triceps area. He also complained of parathesis in the fourth and fifth fingers and hand weakness. Medication and active physiotherapy did not resolve symptoms.

Initial surgeon examination indicated weakness and motor deficit of the C7 myotome together with numbing of the corresponding dermatome and decreased triceps reflex on the left side. A clinical diagnosis of C7 radiculopathy due to disc pathology was made. Following MRI scan, a large C6/7 herniation consistent with the diagnosis was identified.

Due to failed conservative therapy, surgical treatment was recommended. An anterior procedure with Simplify Disc at C6/7 was recommended. Simplify Disc is comprised primarily of MRI compatible materials featuring two PEEK endplates articulating on a ceramic core.

During the procedure the patient was positioned supine with all pressure points attended to and the neck in mild extension. An anterior access was created and the correct level was confirmed fluoroscopically. Discectomy was followed by elongation of the PLL. Simplify Disc was implant- ed with correct positioning and confirmed fluoroscopically. The soft tissue was examined and a routine closure followed. The patient was transferred to intensive care and mobilized with physiotherapy.

Radiological examination followed at 6-weeks post-operatively. The final diagnosis was con- firmed as C7 radiculopathy due to left sided disc herniation. The patient was followed up at 12 months post-operatively without requiring a CT scan and was confirmed to be pain-free without using analgesics. He has resumed normal activities and work program.

Pre-operative MRI

Pre-operative MRI

Pre-operative Lateral View

Post-operative Lateral View

12 Months Post-op Lateral View

12 Months Post-op Lateral Extension View

12 Months Post-op Lateral Flexion View

Case Study 2

Dr. Jacques Scheltema, Johannesburg, South Africa

PATIENT: Middle-aged female patient presented with left-sided C6 radiculopathy and chronic neck pain.

The patient presented with severe C6 radicular pain. Neurological examination confirmed a left-sided C6 radiculopathy with 3/5th power in bicep, brachioradialis supinator and pulse exten- sion. Spinal examination confirmed a chronic stiff neck and decreased range of motion.

Her MRI exam demonstrated a C5/C6 acute and chronic disc herniation, centrally and to the left. She had chronic disease throughout the neck and stress view revealed a stable neck. She had been treated conservatively with analgesics and anti-inflammatory medication. The diagnosis was confirmed as C5/C6 radiculopathy due to disc herniation.

Due to chronic disc herniation, surgical treatment was recommended. An anterior procedure for disc replacement at C5/C6 was recommended. Procedurally, the patient was positioned supine with the neck in mild extension. Under general anesthesia, an anterior access was created at the C5/C6 level and confirmed fluoroscopically. A C5/C6 discectomy and decompression were per- formed with a surgical microscope and the disc space was completely cleared.

A lordotic height Simplify Disc was implanted at the C5/C6 level. Simplify Disc is comprised primarily of MRI compatible materials featuring two PEEK endplates articulating on a ceramic core. Correct positioning was confirmed fluoroscopically. Hemostasis was achieved and a routine closure followed.

The patient was transferred to intensive care and mobilized immediately. Her stay there was uncomplicated and she was discharged after 24 hours from intensive care and within four days from the hospital. Upon discharge she felt no pain.

At 6-weeks post-operatively, the patient had no pain and the power in her arm improved to 4/5th. She had normal range of motion of the neck and X-rays confirmed that the Simplify Disc prosthesis was in the correct position and performing well.

The patient was followed up post-operatively without requiring a CT scan and was confirmed to be pain-free and back to normal activities.

Pre-operative MRI

Post-operative MRI

Intraoperative Positioning

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