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January 2015

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  • How to Prevent Guidewire Coatings from Flaking
    How to Prevent Guidewire Coatings from Flaking

    Posted: 1/26/2015
    The medtech industry appears to have a flaking wires issue-and the main answer to it may involve more stringent fundamentals around a gold-standard coating substance that has lost some of its luster.
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  • Bruce Nesbitt Speaks about PFOA and EPA Regulations
    Posted: 1/26/2015
    Watch as Bruce Nesbitt explains the mandatory removal of PFOA from the presently specified PTFE coatings and the EPA's position on the new regulations. Then, he covers the range of new coatings that are being developed and tested that comply with the EPA regulations and the pros and cons of each new type of coating.
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  • Breakthrough in PTFE-coated Guidewires
    Breakthrough in PTFE-coated Guidewires

    Posted: 1/26/2015
    With most biomedical procedures, success is measured in fractions of an inch--more commonly, microns. Exact friction-free insertion of guidewires, hypotubes, catheters, cannulas, stents, balloons, drug-delivery catheters, cameras, and tissue samplers is critical to the success and safety of every procedure.

    PTFE-coated guidewires are often used in the first step of many minimally invasive medical procedures. The preferred performance of a device is to have the lowest friction at the surface of the wires. Surface Solutions Group, LLC (SSG) of Chicago is a fully automated coating applicator for these and other biomedical devices.
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  • Perfecting PFOA-free PTFE Coating Adhesion
    Perfecting PFOA-free PTFE Coating Adhesion

    Posted: 1/26/2015
    Recall is the last word a biomedical business wants to hear. But that is what struck the guidewire industry last year after a voluntary recall - that the FDA classified as Class 1- for stainless steel guidewires going back to April 2013. The problem was poor adhesion of an aqueous PFOA-free PTFE coating that resulted in flakes of coating being dislodged from guidewires during in vitro procedures. According to the FDA, cardiac arrest can be caused by coating flakes that get lodged in the intravascular system.


    This problem was first noticed when flakes of aqueous green PTFE were discovered in saline tanks of operating rooms uring procedures using guidewires to install stents, balloons, etc. FDA reports in at least one of these instances, the coating flakes resulted in patient injury, although not fatal. This triggered the first recall alarm. Later reports of green flakes in sterilized packages of guidewires caused more concern. Solvent-base PFOA-free PTFE coatings were not involved in any recalls by the FDA.
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  • The Solution to Delamination after the FDA Ban on PFOA
    Posted: 1/26/2015
    The demand by the EPA that manufacturers eliminate PFOA from their PTFE formulations by 2015 appears related to a series of crises for some medical manufacturers due to loss of coating adhesion on guidewires. A recent FDA Class I recall notice states: "There is a potential for PTFE (polytetrafluoroethylene) coating to delaminate and detach from guide wires." The FDA goes on to say, "Uses of this recalled product may result in serious adverse health consequences."
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  • SSG to Move to a New, Larger Dedicated Facility
    SSG to Move to a New, Larger Dedicated Facility

    Posted: 1/26/2015
    Surface Solutions Group is Expanding! SSG is moving in 2014 to a new location called our "Campus."

    The new facility is being purposely built for the application, research and development of coatings for the medical device industry. This represents a 5x expansion in floor space, from 6,500 to 34,000 square feet. The new facility will have 11 separate HVAC zones. Each new production line will be individually qualified, with the complete facility in place by November. SSG will maintain the present facility until all new lines are validated per our customers' requirements.
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