MODULAR ATP Study of the mCRM System Meets Primary Safety and Efficacy Endpoints

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Boston Scientific Corporation (NYSE: BSX) today announced positive six-month results from the ongoing pivotal MODULAR ATP clinical trial of the mCRM™ System,* the first modular cardiac rhythm management (CRM) system. This system consists of the EMBLEM™ Subcutaneous Implantable Defibrillator (S-ICD) System and the EMPOWER™ Leadless Pacemaker (LP). The devices are designed to work together wirelessly to coordinate painless intracardiac anti-tachycardia pacing (ATP) therapy, provide rate-responsive bradycardia pacing support, and prevent sudden cardiac death without the risk of leads in the heart or under the sternum. Findings were presented at Heart Rhythm 2024, the annual meeting of the Heart Rhythm Society, and simultaneously published in The New England Journal of Medicine.

“We saw excellent overall clinical performance of the mCRM System in this study, including a high rate of communication success from the S-ICD to the leadless pacemaker, and a low rate of major leadless pacemaker complications,” said Prof. Reinoud Knops, M.D., Ph.D., Department of Cardiology and Electrophysiology, Amsterdam UMC, Amsterdam, Netherlands. “These findings are noteworthy, as high percentages of communication success and pain-free termination of spontaneous arrhythmia episodes indicate a potential upgrade pathway for patients currently implanted with an S-ICD who develop a need for ATP or pacing.”