Element Materials Technology (Element), one of the world’s leading providers of testing, inspection and certification services to the international medical device sector, has co-authored a peer-reviewed journal article in collaboration with the U.S. Food and Drug Administration (FDA).
Element has developed a method of assessing nickel ion release from nitinol stents that have been fatigue loaded to mimic physiologically-relevant conditions. A collaboration with the FDA was initiated to jointly study whether fatigue loading accelerates nickel ion release.
Published in the Shape Memory and Superelasticity, Advances in Science and Technology journal by Springer, the article titled “The Impact of Fatigue Testing and Surface Processing on Nickel Release in Nitinol Stents” summarizes the findings which highlight the impact of fatigue loading on uniform corrosion for different nitinol stent surfaces.
Rick Sluiters, EVP Aerospace, commented: “We are delighted to work with the FDA on this important study of better understanding the impact of fatigue loading on nickel release from nitinol stents.
“As a global leader in medical device testing, we will continue to deepen our expertise and develop collaborations that advance knowledge and bring safe devices to the market.”
Element’s medical device laboratories, located in the Americas and Europe, provide a comprehensive range of mechanical testing and product qualification testing on hip, knee & spinal implants; trauma devices; cardiovascular & orthopaedic devices, and implantable, diagnostic and therapeutic equipment. Element offers consulting and testing services in prototype development, polymer synthesis and materials selection, coatings and adhesives, 510(k) and CE submissions and a wide range of failure and contaminant investigation capabilities.