18.05.2024 18:47:08 - dpa-AFX: Boston Scientific : MODULAR ATP Study Of MCRM System Meets Primary Endpoints
WASHINGTON (dpa-AFX) - 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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