MDA (Medical Devices Agency) eyes Boston stent fractures
This article was originally published in Clinica
The UK Medical Devices Agency (MDA) has warned of the potential radial fracture of coronary stents made by Boston Scientific Scimed, after the company recently reported that there had been nine such incidents since March 2000. Last week's Device Alert affects five NIRoyal (NIR) products, namely the NIR stent, the NIR premounted stent system (PSS), the NIR Advance PSS, the NIR Elite Monorail PSS and the NIR Elite over-the-wire PSS. Around 200,000 Boston NIR stents have been distributed worldwide since they were first marketed in 1998.
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