Boston Scientific presented the final results from the UNTOUCHED study of the EMBLEM™ Subcutaneous Implantable Defibrillator (S-ICD) System presented at HRS 2020 SCIENCE.
The global, prospective, non-randomized UNTOUCHED study evaluated the safety and efficacy of the EMBLEM S-ICD System for primary prevention of SCD, specifically in patients with a LVEF ≤35%.
Data demonstrated S-ICD therapy had an inappropriate shock-free rate of 95.9% at 18-months post-procedure, meeting the primary endpoint with a rate comparable to or lower than those seen in previous S-ICD and transvenous implantable cardioverter-defibrillator (TV-ICD) studies, conclusively showing high efficacy and safety of the EMBLEM S-ICD for patients without pacing indications.
Results for the investigator-sponsored, prospective, randomized, head-to-head PRAETORIAN trial using the EMBLEM S-ICD were also presented, indicating that the S-ICD can be the preferred therapy choice for the majority of ICD-indicated patients without a need for pacing as it offers comparable performance while avoiding lead-related complications and serious infections associated with TV-ICDs.