ENSINGER GmbH, a supplier and processor of engineering and high performance plastics, has announced a marketing agreement with Invibio®, a leading provider of biomaterial solutions to the medical device market.
Through this new agreement, ENSINGER will immediately begin marketing Invibio’s PEEK-CLASSIX™ polymer – a medical grade polyetheretherketone – for use in the production of medical applications and instruments, to its medical and pharmaceutical customers. ENSINGER will market the material under the name TECAPEEK Classix.
ENSINGER’s customers will benefit from the reduced development time and costs associated with biocompatibility testing and regulatory approvals. Invibio’s polymers have been tested to industry standards, and device masterfiles containing these results have been lodged with the FDA. Making this kind of information available to device manufacturers can help to reduce the time and costs involved for device clearance with regulatory agencies.
Invibio’s PEEK-CLASSIX polymer is a US Pharmacopoeia Class VI thermoplastic designed for medical device applications requiring blood or tissue contact of less than 30 days, including catheters, surgical instruments, analytical equipment, blood management, drug delivery systems and, eg, probe heads for pharmaceutical equipment. It is one of the most chemically resistant polymers available and can be repeatedly sterilised using conventional sterilisation methods, including steam, gamma radiation and ethylene oxide processes without the degradation of its mechanical properties. The material exhibits a superior combination of strength, stiffness and toughness, making it ideally suited for medical device applications.
“This agreement will enable ENSINGER to extend its reach in the worldwide medical manufacturing market,” said Business Development Manager, Dr Jurg Wiedler. “TECAPEEK Classix is the perfect complement to our current portfolio of high performance plastics designed for medical applications.”
“Metal components are increasingly being replaced by medical grade PEEK in the development of medical devices and equipment,” said Michael Callahan, President of Invibio. “Invibio will continue to work with leading suppliers such as ENSINGER to increase the availability of biocompatible, high-performance materials to meet the growing demands of the medical device industry.”
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