Boston Scientific has announced six-month positive results from its ongoing pivotal MODULAR ATP clinical trial examining the company’s modular cardiac rhythm management (mCRM) technology.
The findings published in the New England Journal of Medicine detail how the system successfully met its primary and secondary endpoints in terms of safety and efficacy, seeing 97.5% of participants experience no complications following the procedure, with an anti-tachycardia pacing (ATP) success rate of 61.3%.
The Boston Scientific device consists of an Emblem subcutaneous implantable defibrillator (S-ICD) system and Empower leadless pacemaker (LP) which coordinate painless intracardiac anti-tachycardia pacing.
Cardiology and Electrophysiology consultant for Boston Scientific, Reinoud Knops said: “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.
“These findings are noteworthy, as high percentages of communication success and pain-free termination of spontaneous arrhythmia episodes indicate a potential upgrade pathway for patients currently implanted with an S-ICD who develop a need for ATP or pacing.”
Boston Scientfic’s findings were presented before an audience at the Boston-based Heart Rhythm 2024 conference where the company also revealed results from its APPRAISE ATP clinical trial, a prospective, randomised, multicenter study evaluating ATP as a method of treating ventricular tachycardias in primary prevention (PP) patients. That trial has enrolled 2,626 patients indicated to receive an ICD at 134 centres worldwide.
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Kenneth Stein, chief medical officer for Boston Scientific, said: “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.
“Instead of subjecting all patients to the risks of more invasive approaches, such as placing leads in the heart or tunnelling them under the sternum to provide therapies they might not require, these data indicate physicians may have the opportunity to tailor therapy to the patient's individual needs and health."
Elsewhere in the field of anti-tachycardia pacing, health tech company Element Science has received an EU CE mark certification and UK Conformity Assessed (UKCA) marketing for its own digital wearable defibrillator. At the same time, the US Food and Drug Administration (FDA) has approved Medtronic’s Aurora EV-ICD MRI SureScan extravascular implantable cardioverter-defibrillator.
