Heart Rhythm 2024: Boston Scientific Touts Positive Data for Modular CRM

Boston Scientific announced positive, six-month results of its ongoing pivotal MODULAR ATP trial of its mCRM system.
 
The mCRM system is a modular cardiac rhythm management (CRM) system consisting of the Emblem subcutaneous implantable defibrillator (S-ICD) and Empower leadless pacemaker (LP). The devices work together wirelessly to coordinate painless intracardiac anti-tachycardia pacing (ATP) therapy, provide rate-responsive bradycardia pacing support and to prevent sudden cardiac death without the risk of leads in the heart or under the sternum.
 
The findings were presented at Heart Rhythm 2024 and simultaneously published in The New England Journal of Medicine.
 
The Empower LP’s safety and efficacy as a standalone pacemaker was evaluated. Also evaluated was the Emblem S-ICD’s ability to successfully communicate a wireless request to the LP to deliver ATP therapy.
 
A major complication-free rate of 97.5% was shown after the Empower LP was implanted. A communication success rate of 98.8% from the Emblem S-ICD to the Empower LP was also demonstrated. There was an ATP success rate of 61.3% and no patient requests to deactivate ATP or bradycardia pacing due to pain or discomfort.
 
“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.”
 
Boston Scientific said it expects U.S. Food and Drug Administration (FDA) approval of the mCRM system in 2025.
 
“Together, data from the MODULAR ATP and APPRAISE ATP trials reinforce the promise of the groundbreaking mCRM System, illustrating a clear path forward for physicians to offer therapies that prevent sudden cardiac death and deliver ATP for the small number of patients who benefit from it,” said Kenneth Stein, M.D., senior VP and global chief medical officer, Boston Scientific. “Instead of subjecting all patients to the risks of more invasive approaches, such as placing leads in the heart or tunneling them under the sternum to provide therapies they might not require, these data indicate physicians may have the opportunity to tailor therapy to the patient’s individual needs and health.”