The Journal of the ‘American College of Cardiology’ reported data confirming the long-term efficacy and safety of the Boston Scientific Corporation (NYSE:BSX) S-ICD™ System for patients at risk of unexpected cardiac arrest. The trial was led by Dr. Martin Burke who is Professor of medicine at one of the reputed universities, The University of Chicago. The study combined data from two S-ICD studies to give the most comprehensive look at System patient results to date.
Boston Scientific’s S-ICD System was approved by the FDA in year 2012. It fetched Category 1 CPT Codes in last January. The system was represented to be highly effective, transforming more than 98% of heart arrhythmias that can result in sudden death. The trial data are comparable to efficacy results recorded in transvenous ICD clinical trials 1-4.
The journal stated that when evaluating 889 patients, there were no systemic infections and lead failures linked with the Boston Scientific’s S-ICD System. The data revealed that the total complication rate was low compared to rates seen in relative TV-ICD studies 5, 6. Also, the cumulative complications rate increased just 1% annually after the first year. The major acute complications associated with the operations were lower relative to TV-ICD studies 7, 8.
The expert view
Dr. Burke said that Boston Scientific’s S-ICD system sits below the skin without any need for leads or electrodes to be put into the heart and therefore it makes sense that the team sees lower serious complications. By using the BSX S-ICD System the experts can avoid the crucial risks that result in endovascular or systemic infections, which can result in elongated hospital, stay and incur incremental hospital costs. The endovascular or systemic infections are also linked with mortality for up to almost 30% of TV-ICD patients who get this type of infection.