Results from EFFORTLESS registry study on Emblem Subcutaneous Implantable Defibrillator show efficacy for cardiac arrest- Boston Scientific

Boston Scientific has announced results from the largest post-market registry for the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System. Data confirmed long-term safety and efficacy for the only device available to treat sudden cardiac arrest without leads touching the heart and vasculature. Primary results demonstrate low complication rates associated with the S-ICD device, with a complication-free rate of 99.7% at 30 days, and 98.0% at 360 days post-procedure. The efficacy of the S-ICD System was further validated in this analysis, with a 97.4% conversion rate of discrete arrhythmias that can lead to sudden death.

Follow-up at an average 3.1 years revealed that few S-ICDs were removed due to a change of patient indication. Only five (0.5%) S-ICDs were removed in order to implant a patient with a defibrillator with anti-tachycardia pacing capabilities, and only one (0.1%) was removed to allow for a device with bradycardia pacing capabilities. The multi-national registry included 985 patients who were observed for up to five years post-implant � more than any S-ICD data the company has previously published. Data collected from the EFFORTLESS study were presented at the 37th Annual Scientific Sessions of the Heart Rhythm Society.

Comment: Unlike traditional ICDs that require placement of at least one lead in or on the heart, the S-ICD System is implanted just under the skin and provides the patient the same protection from cardiac arrest without invading the heart and blood vessels.