Boston Scientific Corp. (BSX) has reported encouraging six-month outcomes from the pivotal MODULAR ATP clinical trial of its mCRM System. This innovative system is the first modular cardiac rhythm management system, encompassing both the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System and the EMPOWER Leadless Pacemaker.
The devices in this system are engineered to function wirelessly, coordinating the delivery of painless intracardiac anti-tachycardia pacing (ATP) therapy, providing rate-responsive bradycardia pacing support, and preventing sudden cardiac death without the associated risks of having leads in the heart or beneath the sternum.
The trial focused on the EMBLEM S-ICD System's capability to wirelessly communicate with the EMPOWER Leadless Pacemaker to effectively administer ATP therapy. According to Boston Scientific, the results met all pre-specified six-month safety and effectiveness endpoints. These results showcased a major complication-free rate of 97.5% post-implantation of the EMPOWER Leadless Pacemaker, a communication success rate of 98.8% between the EMBLEM S-ICD System and the EMPOWER Leadless Pacemaker, an anti-tachycardia pacing success rate of 61.3%, and no patient requests for deactivation of either ATP or bradycardia pacing due to pain or discomfort.
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