Boston Scientific has become aware of new information related to valve underexpansion, that emerged from review of the 1-year clinical trial data from the ACURATE IDE. Detailed investigation of the 1-year data identified valve underexpansion as a potential leading contributing factor of the missed primary endpoint (ACURATE neo2 non- inferiority to the Control group for the composite of death, stroke and rehospitalisation). ACURATE neo2 valve underexpansion was associated with an increased rate of primary endpoint events compared to cases where the ACURATE neo2 valve was well expanded. However, valve underexpansion was not previously identified through clinical experiences with the ACURATE neo2 valve nor through ACURATE neo2 post market surveillance. The Instructions for Use (IFU) have been updated to include the risk of valve underexpansion and the practices that may reduce this risk. Recall start date: November 7, 2024
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