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MD&M 2010 Presentation: FDA Approach to Preclinical Testing

This MD&M Minneapolis presentation by Jonathan Peck discusses the role of non-clinical testing in the medical device clearance/approval process at FDA. More specifically, the talk will attempt to cover some of the general pros and cons of bench testing, animal testing, and modeling (FEA). Relevant to PEEK, the topic of material selection and the 522 order on motion preserving spine implants are covered in the talk.

Self-Initiated Surface Grafting with PMPC on PEEK

Researchers from Japan have synthesized an antibiofouling and highly hydrophilic high-density nanometer-scaled layer on the surface of PEEK by photo-induced graft polymerization of 2-methacryloyloxyethyl phosphorylcholine (MPC) without using any photo-initiators, i.e., "self-initiated surface graft polymerization." The results indicated that the diphenylketone moiety in the polymer backbone acted as a photo-initiator similar to benzophenone. This photo-induced polymerization process occurs only on the surface of the PEEK substrate; therefore, the desirable mechanical properties of PEEK would be maintained irrespective of the treatment used.

Patient Perception of Outcomes Following Failed Spinal Instrumentation with PEEK and Titanium Rods

The purpose of this study was to determine whether material rod composition and its imaging characteristics can determine patient perceptions of pain, outcome, and need for revision surgery in the context of the failure of spinal instrumentation following lumbar arthrodesis. Back pain patients completed a questionnaire containing 3 alternative radiographic images of failed rod instrumentation following posterolateral lumbar fusion surgery. The images represented failed rods composed of either PEEK, PEEK with a longitudinal radio-opaque marker, or traditional titanium. The responses suggested a preference for the images representing PEEK instrumentation as being associated with superior clinical outcomes, the least pain, the most comfort, and the least likelihood of required revision surgery.

Inflammatory Response of CFR-PEEK Wear Particles Compared with UHMWPE in vivo.

The objective of this project was to evaluate the biological response of two different kinds of carbon fiber-reinforced (CFR) PEEK compared with ultra-high molecular weight polyethylene (UHMWPE) in vivo as a standard bearing material. Wear particles of the particulate biomaterials were injected into the left knee joint of female BALB/c mice. The results of this study suggest that wear debris of CFR-PEEK is comparable with UHMWPE in its biological activity.

Electron Beam Deposition of Titanium on PEEK and Biological Response

The surface of polyetheretherketone (PEEK) was coated with a pure titanium (Ti) layer using an electron beam (e-beam) deposition method in order to enhance its biocompatibility and adhesion to bone tissue. The Ti coating layer strongly adhered to the PEEK substrate and remarkably enhanced its wettability. The Ti-coated samples were evaluated in terms of their in vitro cellular behaviors and in vivo osteointegration, and the results were compared to a pure PEEK substrate. In vivo animal tests showed that the Ti-coated PEEK implants had a much higher bone-in-contact (BIC) ratio than the pure PEEK implants.

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