MODULAR ATP Study of the mCRM™ System Meets Primary Safety and Efficacy Endpoints
Additional data from APPRAISE ATP trial reinforce modular therapy approach with EMBLEM™ Subcutaneous Implantable Defibrillator and EMPOWER™ Leadless Pacemaker
In addition to evaluating the safety and performance of the
- A major complication-free rate of 97.5% after implantation of the
EMPOWER LP .1 - A communication success rate of 98.8% from the EMBLEM S-ICD System to the
EMPOWER LP .2 - An ATP success rate of 61.3%,3 and no patient requests for deactivation of ATP or bradycardia pacing due to pain or discomfort.
- Pacing capture thresholds, which indicate stable device fixation within the heart, of ≤ 2.0 V at 0.4 ms in 97.4% of patients.
"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.
Also presented at Heart Rhythm 2024 were results from the APPRAISE ATP clinical trial – a prospective, randomized, multicenter study evaluating ATP as a primary strategy for terminating ventricular tachycardias in primary prevention (PP) patients (i.e., those without a history of spontaneous sustained ventricular arrhythmias). The trial enrolled 2,626 PP patients indicated to receive an ICD at 134 centers globally and is the largest head-to-head trial of ATP in this patient group. In the study, patients were randomized 1:1 to standard transvenous-ICD therapy – ATP plus an ICD-delivered shock to terminate a ventricular tachycardia – versus shock only. Across five years of follow up, data demonstrated a statistically significant, but small absolute first all-cause shock reduction in only 1% of patients per year. Shock burden, or the number of shocks experienced by a patient, was not significantly different between the two arms, and the vast majority of patients in the ATP-plus-shock arm did not require ATP therapy.
"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
The company anticipates
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**Dr.
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1 Major complications defined as any complication related to the
2 During communication tests, the S-ICD attempted to command the LP to deliver pacing at a rate approximately 10 beats per minute faster than the patient's intrinsic rhythm.
3 ATP success rate defined as terminating ventricular arrhythmia.
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