Investigators presented data from the MODULAR ATP study at the ESC Congress in London this week. It evaluates the Boston Scientific mCRM (modular cardiac rhythm management) system. The mCRM system features a novel leadless pacemaker (LP) with wireless communication that pairs it with a subcutaneous implantable cardioverter defibrillator (S-ICD). This combination delivers anti-tachycardia pacing (ATP) and bradycardia pacing to patients while avoiding transvenous lead complications.
Boston Scientific’s mCRM system utilizes the Emblem MRI S-ICD system and the Empower modular pacing system (MPS). The company previously touted it as the first leadless pacemaker capable of delivering both bradycardia pacing support and ATP. Boston Scientific reported earlier positive data for the system at Heart Rhythm Society 2024 in May.
More on the data
Outcomes reported at ESC focus on 293 patients enrolled in the study as of Jan. 24, 2024. Investigators looked at Empower’s performance in rate-adaptive pacing and pacing in the ambulatory setting, respectively.
Key findings include a high rate of successful leadless pacemaker implantation with few complications and stable pacing parameters. Boston Scientific reports that the rate-response sub-study (35 participants) measured the leadless pacemaker’s accelerometer response to support rate-adaptive pacing. Another 31 patients underwent Holter monitoring to confirm ambulatory performance.
Pacing performance measures came in as stable and within acceptable ranges, Boston Scientific said. The Holter sub-study showed appropriate pacing behavior. Additionally, at six months, 97% of patients had a pacing burden less than or equal to 10%.
“Successful performance of the Empower leadless pacemaker in the MODULAR ATP study provides crucial evidence that it will function as a standalone pacemaker to treat bradycardia, in addition to its anti-tachycardia pacing capabilities when used in connection with the Emblem S-ICD,” said Dr. Kenneth Stein, SVP and global chief medical officer, Boston Scientific. “We believe this device will provide additional options for physicians to treat cardiac arrhythmias, without subjecting patients to the risks of more invasive, lead-based approaches – a capability that will make it a strong addition to the Boston Scientific portfolio.”
