Product category:
Materials and components
News Release from: Invibio | Subject: Peek-Optima
Edited by the Engineeringtalk Editorial
Team on 31 July 2001
Polyaryletherketone for finger implant
stems
Mathys Medical of Bettlach, Switzerland, has replaced acetal with Invibio Peek-Optima polyaryletherketone for its range of finger implant stems.
Mathys Medical of Bettlach, Switzerland, has replaced acetal with Invibio Peek-Optima polymer for its range of finger implant stems Peek-Optima is ideally suited for in-vivo medical device applications as it combines outstanding chemical and hydrolysis resistance, high strength and excellent tribological properties with extensive biocompatibility
Peek-Optima polyaryletherketone is manufactured using enhanced manufacturing technology.
Stringent physical, chemical and mechanical testing is carried out at key stages of the production process.
The result is a highly reliable implantable material that is designed to meet the most rigorous performance criteria.
Michael Callahan, Managing Director of Invibio explains: "Compared to acetal, Peek-Optima polymer demonstrates superior resistance to chemicals, radiation and steam, as well as better mechanical properties such as strength, rigidity and toughness.
This provides high quality, durable medical devices that can withstand repeated sterilization by all standard techniques.
Furthermore Peek-Optima's exceptional wear and frictional resistance helps to minimize degenerative or accident -related impairment in applications such as synthetic finger joints.
Another advantage of the polymer is that it offers full compatibility with computer tomography and MRI spectroscopy.
The polymer is inherently radiolucent (X-ray transparent) but Invibio also offers a custom-manufactured grade of Peek-Optima polymer to achieve a radiopaque (X-ray visible) device.
Mathys selected the customised grade for the finger implants to facilitate post-operative inspection of both the device and the adjacent bone.
Invibio has performed extensive biocompatibility and biostability testing on Peek-Optima polymer.
These results, including ISO 10993 and USP Class VI, are contained in detailed Master Files at the FDA.
These include Device Master Files (MAF) and Drug Master Files (DMF).
"Making this kind of documentation readily available to the manufacturer helps to reduce the time and costs involved for device clearance with regulatory agencies," explains Callahan.
The exhaustive clinical evaluation of implants typically leads to long development times.
Invibio has therefore made a commitment to device manufacturers to ensure the continuity of supply of Peek-Optima polymer through a 'no-change' agreement.
This guarantees the specification and availability of the polymer over an extended period of time, as agreed with the customer.
One of the reasons why Peek-Optima polymer is attracting so much attention as an implant material is that material modifications can be tailored to meet specific applications.
Mr.Callahan continues: "In orthopaedic implants, for example, the modulus and mechanical strength of Peek-Optima polymer can be adjusted to closely match that of bone.
This helps to counteract 'stress shielding' which is widely believed to lead to implant failure." The polymer opens up therefore new application opportunities for Mathys Medical as well as improving the performance of existing products such as the finger joints.
Invibio provides biomaterial solutions for the implantable medical device market.
Peek-Optima polymer is produced at its headquarters and manufacturing facility in the United Kingdom.
With offices also in the USA and Europe it is the sole world-wide manufacturer and distributor of Peek-Optima polymer, an advanced biomaterial suitable for long term implantation.
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