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Australia warns on balloon-expandable stents:

This article was originally published in Clinica

Executive Summary

The Australian Therapeutic Devices Branch (TDB) has issued a warning in the Australian Therapeutic Device Bulletin on inappropriate balloon-expandable stent placement resulting from the failure of balloons to expand fully. Data collected by the TDB, together with data from the US Medical Device Reports, indicate that most faults occur with larger stent-balloon size combinations, or when using stents mounted on the largest possible balloon size. The TDB stresses that it is imperative the balloon be inflated to the recommended pressure specifications. It "strongly recommends" that an inflation device with a manometer be used to minimise the risk of overinflation.

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