Synthesis and Processing of PEEK for Surgical Implants - PEEK Biomaterials - page 12

Table 2.1 Summary of PAEK Materials Related to Implant Use

Polymer Trade Name Producer Comments

PEEK OPTIMA

(Biomaterial)

Invibio (subsidiary of Victrex),
Thornton-Cleveleys, United
Kingdom

Manufacturer and supplier of long-
term implantable PEEK in CE and
Food and Drug Administration-
approved devices since 1998

PEK Invibio (subsidiary of Victrex),

Thornton-Cleveleys, United
Kingdom

Available only in experimental
quantities (see Chapter 13)

PEEK Victrex Victrex, Thornton-Cleveleys,

United Kingdom

Provides PEEK for blood/tissue
contact less than 24 h

PEEK Gatone Gharda, India No record of supplier implantation

studies. Discontinued for medical
use when acquired by Solvay in
December 2005

PEEK Keta-Spire Solvay Advanced Polymers,

LLC

Not available for implant use

PEEK Zeniva Solvay Advanced Polymers,

LLC

Implantable grade available

PEEK VESTAKEEP I Evonik Implantable grade available

PEKK PEKK DuPont, Wilmington, DE Discontinued for medical use by

DuPont

PEKK OXPEKK OPM, Enfield, CT Implantable grade available. Base

resins supplied by Cytec [9]

PEKEKK Ultrapek BASF, the United States Discontinued in December 1995

Historically, PAEK materials, including PEEK,
have been produced primarily as niche polymers for
industrial use, because their cost even today is at least
two orders of magnitude more expensive than low-
temperature thermoplastics such as polyethylene.
When ICI launched Victrex PEEK in 1987, the
primary application targets were not medical.
However, Victrex PEEK was used, if not yet sup-
ported, for implant applications. The Victrex PEEK
business was sold by ICI in 1993, and in 1998, Victrex
launched PEEK-OPTIMA for long-term implant-
able applications. The offering of PEEK-OPTIMA
provided a higher specification product and was
aimed at addressing the previous failings of PAEK
polymers by offering long-term supply assurance
agreements in addition to a policy of no change con-
cerning the main characteristics of polymer proper-
ties. PEEK-OPTIMA was supported by drug and

device masterfiles and manufactured in compliance
with Good Manufacturing Practice. In 2001, Victrex
established Invibio Biomaterial Solutions to specifi-
cally provide grades of PEEK suitable for long-term
implantation. In reviewing the historical PEEK liter-
ature, whether for industrial or biomedical applica-
tions, the reader should keep in mind that polymers
from ICI, Victrex, and Invibio were all produced at
the same plant location, although the name of the
company has changed since that time. Similarly, the
nomenclature for the resin grades has changed over
time, but the polymerization technology has remained
fundamentally similar ( Table 2.2 ). Today, PEEK
biomaterials are designated by the OPTIMA trade
name based on their molecular weight, which governs
their flow properties in the melt ( Table 2.2 ). The same
range of molecular weight of PEEK polymers was
also previously available from Victrex.