When choosing cranioplasty implants, how do you know which option is best? Know the pro’s and con’s of each material and application.

Here is a list of cranioplasty products used to fill voids and patch defects in the cranial skeleton. The information below has been gathered from whitepapers and anecdotally from representatives in the field in an effort to best evaluate the market for cranial implants.

The Materials

MedCAD AccuShape® PEEK

PEEK (poly ether ether ketone) is the preferred material for cranioplasty implants in hospitals around the world. It is the “gold standard” for large defects and also well suited for small and standard defects. While the perception of PEEK is premium, MedCAD is continually improving the patient-specific medical device process in a way that makes PEEK competitive against all options.

• PEEK Pro’s: tough, durable, similar to cortical bone, receptive to common titanium fixation and screws, bio-inert, radiolucent, customized fit and ability to provide finely tapered edges, easy to remove if needed, manufactured patient-specific for minimal modification in OR
• PEEK Con’s: may not support soft tissue adhesion due to its inert characteristics
• MedCAD PEEK vs. Other Companies: MedCAD provides patient-specific PEEK implants to meet customer-specific needs like timeframe, customization, and high quality. Other companies offer patient-specific PEEK implants in two weeks or more while MedCAD delivers within 4-5 days on average.

PEKK

PEKK (poly ether ketone ketone) is a 3D-printed variant similar to PEEK material, operating in much the same way as PEEK. The 3D-printing process of PEKK leaves pores in the implant that the manufacturer sells as “promoting bone growth” while MedCAD would flag the implant as a sterilization risk.

• PEKK Pro’s: Marketed minor osseointegration, manufactured patient-specific, similar to cortical bone
• PEKK Con’s: Porous, potential sterilization risk, may not support soft tissue adhesion due to its inert characteristics
• PEKK vs. PEEK: Comparable, PEEK may be easier to sterilize

PMMA or Acrylic

PMMA (polymethyl methacrylate) or Acrylic is useful in procedures needing increased modification.

• PMMA Pro’s: Cost effective, not likely to break when modified with a burr tool
• PMMA Con’s: PMMA traps microscopic air bubbles when manufactured – increasing risk of unsterilized exposure if modified in OR
• PMMA vs. PEEK: PEEK is stronger, PEEK is autoclavable vs. PMMA gas or gamma sterilization

Titanium Mesh (and Bone Cement)

Titanium mesh and bone cement are commonly used in cases with a smaller defect sizes (under 100cm²) with the expectation of vascularizing the void with hydroxyapatite. While bone cement quickly begins osseointegration with patient anatomy, it may take several years to fully integrate.

• Titanium Mesh Pro’s: osseointegrates with patient anatomy, customizable
• Titanium Mesh Con’s: extended customization time in the OR, risk of sharp edges, “checkerboard pattern” through patient skin in cases without bone cement
• Titanium Mesh vs. PEEK: PEEK is stronger and more durable (similar to cortical bone)
  

• Bone Cement Pro’s: osseointegrates with patient anatomy
• Bone Cement Con’s: brittle, messy, wait time for material curing process in OR
  

The combination of titanium mesh and bone cement can amount to reportedly similar costs to PEEK if you include surgical involvement in the cost analysis. AccuShape PEEK implants, in comparison, are designed to match the defect and require minimal modification.

Porous Polyethylene

Porous polyethylene is a formable material used as a highly customizable cranial implant. Due to the material nature of porous polyethylene, it may not support fixation with titanium screws. Some companies ship two implants (sterile) in the case of a dropped implant.

• Porous Polyethylene Pro’s: Customizable in surgery, cost effective
• Porous Polyethylene Con’s: may crack when screws are applied
• Porous Polyethylene vs. PEEK: porous polyethylene is less expensive, but it is soft and may have trouble holding screw hardware compared to PEEK.
  

Surgical Priority

Value to the patient is key. If the surgical priority is to protect the patient’s brain with a durable and stable implant, PEEK is the best option to perform for the total life of the patient.  Understanding the short and long term surgical goals combined with material information are factors that can help reps sell more, make more money, and deliver quality products.

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MEDCAD TEAM,
Custom Surgical Solutions | Dallas, TX