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Ablysinol (Dehydrated Alcohol) & Atrioventricular Block, Heart Failure, Myocardial Infarction, Permanent Pacemaker Placement, Septal Myectomy, and Ventricular Arrhythmia

    Basic Details
    Last Updated
    Wednesday, November 8, 2023
    Original Posting Date
    Health Outcome(s)
    atrioventricular block
    heart failure
    myocardial infarction
    permanent pacemaker placement
    septal myectomy
    ventricular arrhythmia
    Drug and Outcome Analysis
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    Percutaneous transluminal septal myocardial ablation (PTSMA) is an alternative to surgery for left ventricular outflow tract obstruction in patients with hypertrophic obstructive cardiomyopathy. PTSMA involves injection of dehydrated alcohol into the coronary artery, inducing a localized basal septal myocardial infarction which remodels the outflow tract. Ablysinol, a dehydrated alcohol product, was approved by FDA on June 21, 2018. FDA wanted to understand how approval of this new dehydrated alcohol product would impact the number of PTSMA procedures conducted and subsequent post-procedural complications. 

    FDA conducted a study in the Sentinel System to evaluate changes in the frequency of PTSMA procedures conducted and changes in the occurrence of potential post-procedural complications after approval. After Ablysinol approval in 2018, the frequency of PTSMA procedures per year, the proportion of potential post-procedural complications such as heart failure, atrioventricular block, and permanent pacemaker placement observed, and the proportion of PTSMA procedures requiring a repeat PTSMA procedure, increased only slightly in this study. Evaluation of death was not pursued in this analysis due to under capture in the assessed data. The FDA determined that no regulatory action is needed at this time.