Boston Scientific Corp. (BSX) announced positive six-month results from the ongoing pivotal MODULAR ATP clinical trial of the mCRM System, the first modular cardiac rhythm management system that consists of the EMBLEM Subcutaneous Implantable Defibrillator or S-ICD System and the EMPOWER Leadless Pacemaker.
The company noted that the devices are designed to work together wirelessly to coordinate painless intracardiac anti-tachycardia pacing or 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 company noted that the trial evaluated the ability of the EMBLEM S-ICD System to successfully communicate a wireless request to the LP to deliver ATP therapy.
According to the company, findings from the trial met all pre-specified six-month safety and effectiveness endpoints, and demonstrated a major complication-free rate of 97.5% after implantation of the EMPOWER Leadless Pacemaker; A communication success rate of 98.8% from the EMBLEM S-ICD System to the EMPOWER Leadless Pacemaker; An anti-tachycardia pacing success rate of 61.3%, and no patient requests for deactivation of anti-tachycardia pacing or bradycardia pacing due to pain or discomfort.
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