SIMPLIFY DISC

Product Overview

Simplify® Disc

  • A motion-preserving, cervical artificial disc designed to permit the full diagnostic imaging capability of MRI.

The Future of Cervical Arthroplasty

  • Simplify Disc is composed of polymer & ceramic composite
  • Simplify Disc requires no CT scanning to image
  • Simplify Disc has no metal wear from articulating components
  • Simplify Disc can minimize patient exposure to high-dose ionizing radiation and the potentially harmful side effects of contrast media injections into the cerebrospinal fluid (CT/Myelogram)

Simplify Disc Description

  • Comprised of polyether ether ketone (PEEK) endplates and a mobile ceramic composite core
  • Biocompatible¹, osteointegrating titanium2 coating on bone contacting endplate surfaces
  • Concave articulating endplate surfaces with retention ring
  • Semi-constrained, fully articulating, self-centering biconvex mobile ceramic core

Clinically Successful Design

  • Simplify Disc is based upon a clinically successful design implanted in >2,000 patients with up to 5 years follow-up
  • Simplify Disc’s design replicates a range of motion (ROM) similar to that of intact natural discs
  • Simplify Disc can be used to treat single level symptomatic cervical disc disease (CDD) from levels C3 to C7

Simplify Disc Key Features & Benefits

  • Anatomic in design
  • Preserves ROM
  • Composed of materials that permit the full diagnostic imaging capability of MRI
  • Reduces exposure to high-dose radiation from CT scans
  • Bony integration promoted with biocompatible¹ porous titanium endplate coating
  • Inserts as one unit using a steamlined three-step procedure
  • Disc heights as low as 4mm to treat a broad range of patients
  • No metal wear from articulating components.
  • Built on clinically successful experience

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 ongrowth2.

 

References:

 

      1. Hallab NJ, et al. Macrophage reactivity to different polymers demonstrates particle size-and material-specific reactivity: PEEK-OPTIMA particles vs UHMWPE particles in the submicron, micron, and 10 micron size ranges J Biomed Mater Res B. 2011. 100B (2); 480-92.
      2. Assem Y., et al. Radiological and clinical outcomes of novel Ti/PEEK combined spinal fusion cages: a systematic review and preclinical evaluation. Eur Spine J. 2015 Dec 15.

Simplify Design

Designed for MRI

  • Advanced medical polymer (PEEK) endplates and ceramic composite core permit the full diagnostic imaging capability of MRI at implant and adjacent levels
  • Other approved cervical disc implants are made of metal alloys, which require CT scans with high-dose ionizing radiation to evaluate tissue adjacent to the artificial disc

Anatomic in Design

  • Simplify Disc heights are designed to better match patients’ anatomies with disc heights ranging from 4mm to 6mm
  • Anatomic heights may produce clinical results which could potentially benefit patients with smaller anatomies
  • The following tables represent disc height data:
    • On 545 untreated adjacent level discs (C3-4 to C6-7) to estimate normal disc height
    • On 332 index level (treated) discs
  • Average disc height was calculated as a mean of anterior and posterior disc height, not central disc height


Designed to Conform to Patient Anatomy

Simplify Disc maximum range of motion without anatomic constraint:

  • +/- 12° flexion/extension
  • +/-12° lateral bending
  • Unconstrained in rotation
  • Heights: 4mm, 5mm, 6mm
  • Footprints: 15x12mm, 15x14mm, 18x16mm

Designed with Lordosis Options

Simplify Disc is available in 0 and 5 degrees lordosis. The lordotic option may benefit patient’s with naturally lordotic cervical discs.


Mobile Bearing Design Closely Replicates Range of Motion

Published clinical data shows mobile bearing design disc maintained motion over time.


Designed for Durability

  • PEEK is considered an advanced biomaterial and is used widely in medical implants including spinal fusion devices
  • Medical grade ceramics have high wear resistance and are used in multiple spinal and orthopaedic devices, including Simplify Disc’s core
  • Ceramics’ low wear rate works well for young, active patients and is well tolerated by the body

“PEEK-OPTIMA particles were more biocompatible than UHMWPE.” 1

Simplify Imaging

The MRI Advantage

  • MRI is the ideal screening method for evaluating patients with cervical myelopathy or radiculopathy3
  • Simplify Disc is made of PEEK and ceramic composite, which allow the index level and adjacent tissues to be visualized when imaged using MRI

MRI of traditional metallic cervical artificial disc with artifact

MRI of PEEK-on-ceramic composite 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 2013.3

 

“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 2012.4

Simplify the Procedure

A Streamlined Three-step Surgical Procedure.

  • Simplify Disc is designed to be inserted as one preassembled unit, enabling efficient
    implantation and decreased intraoperative time
  • Simplify Disc is inserted in three steps
  • Other US-approved cervical artificial discs are inserted as separate components

Step 1. Disc Sizing

Use Simplify Trial to select Simplify Disc size.

Step 2. Slot Cutting

Cut slot to accommodate Simplify Disc stabilizing fins.

Step 3. Disc Placement

Fully insert Simplify Disc as one unit.

Reducing Radiation

Simplify Disc Minimizes Radiation Risks Associated with CT/Myelograms

  • Invasive CT exams are routinely performed after cervical disc replacement, which expose the patient to significant ionizing radiation
  • Simplify Disc advanced polymer and ceramic composite materials are visible using MRI, and virtually eliminate the need for CTs
  • MRI imaging is the most accurate and least invasive way to evaluate cervical discs and adjacent tissues post-operatively3
  • FDA Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging
  • The FDA recommends reducing radiation exposure to patients by the following:
    • Ensure the CT exam is necessary
    • Use other non-radiation exams when possible
    • Avoid duplicate exams

CT scans using high-dose radiation have grown more than six fold in the last 20 years.

  • The radiation dose of CT scans are 100 to 1,000 times higher than conventional X-rays
  • One in ten Americans undergo a CT scan every year
  • A recent NY Times editorial said:
    “The National Cancer Institute estimates that CT scans conducted in 2007 will cause a
    projected 29,000 excess cancer cases and 14,500 excess deaths over the lifetime of those exposed.”

For more information please see our education page and discuss with your physician.

References:

 

      1. Hallab NJ, et al. Macrophage reactivity to
        different polymers demonstrates particle size-and material-specific reactivity: PEEK-OPTIMA particles vs UHMWPE particles in the submicron, micron, and 10 micron size ranges. J Biomed Mater Res B. 2011. 100B (2); 480-92.
      2. Assem Y., et al. Radiological and clinical outcomes of novel Ti/PEEK combined spinal fusion cages: a systematic review and preclinical evaluation. Eur Spine J. 2015 Dec 15.
      3. 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.
      4. Linet MS, et al. Cancer Risks Associated With External Radiation From Diagnostic Imaging Procedures. CA Cancer J Clin 2012; 62(2):75-100.

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