Real-world data demonstrates success of SMART Pass on the S-ICD System

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Results from an analysis of the LATITUDE database which evaluated the successful reduction of inappropriate shocks using the SMART Pass sensing filter in patients implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System have been announced. The real-world data were presented during a late-breaking clinical trial at Heart Rhythm 2018, the Heart Rhythm Society’s 39th Annual Scientific Sessions in Boston, and demonstrated that when the sensing filter was in use, the rate of inappropriate shocks was reduced to 4.3% at one year. The analysis was also published online today in the Heart Rhythm Journal

The SMART Pass sensing filter is an advanced algorithm within the EMBLEM S-ICD System that filters out certain signals that are the primary reason for inappropriate shocks, while maintaining the ability to accurately detect ventricular tachycardia or ventricular fibrillation and deliver lifesaving therapy. Study authors evaluated the effect of SMART Pass on shocks in ambulatory patients and found that the filter reduced the risk for the first inappropriate shock by 50% and the risk for all inappropriate shocks by 68%, without a negative impact on delivery of appropriate shocks.

“The study data validate the clinical benefit of this sensing methodology to significantly reduce inappropriate shocks by the S-ICD,” said Tom F Brouwer, presenting author, Department of Clinical and Experimental Cardiology, Academic Medical Centre, University of Amsterdam, The Netherlands. “At one year, the inappropriate shock rate for patients with the SMART Pass filter in use was as low as rates observed in studies with transvenous implantable cardioverter-defibrillators employing modern programming strategies.”

The prospective, blinded evaluation reviewed one year of remote monitoring data from 1,984 patients that were implanted with an EMBLEM S-ICD System between 2015 and 2016.

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