Boston Scientific Corporation 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 that consists of the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System and the EMPOWER Leadless Pacemaker (LP).

As components of the mCRM System, the devices are designed to 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. 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."

"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 vice president 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."