Modular ATP Study of mCRM™ System Meets Primary Safety and Efficacy Endpoints (Investing.com)

Additional data from APPRAISE ATP trial strengthen modular treatment approach using EMBLEM™ subcutaneous implantable defibrillator and EMPOWER™ leadless pacemaker

marlborough, massachusetts, May 18, 2024 /PRNewswire/—— Boston Scientific Corporation (NYSE: NYSE: ) today announced positive six-month results from the ongoing pivotal MODULAR ATP clinical trial of the mCRM™ System, the first modular cardiac rhythm management (CRM) system powered by the EMBLEM™ subcutaneous implantable defibrillator (S-ICD) system and EMPOWER™ leadless pacemaker (LP). As components of the mCRM System, these devices are designed to work together wirelessly to coordinate painless intracardiac antitachycardia pacing (ATP) therapy, provide rate-responsive bradycardia pacing support, and prevent sudden cardiac death, Without having to worry about the risk of your heart or wires in your heart. The findings were presented at the Heart Rhythm 2024 Annual Meeting. Heart Rhythm Associationand also published in New England Journal of Medicine.

In addition to evaluating security and performance Authorized LP As a stand-alone pacemaker, this trial evaluated the EMBLEM S-ICD System’s ability to successfully send wireless requests to the LP to deliver ATP therapy. The trial results met all prespecified six-month safety and efficacy endpoints and demonstrated:

• The incidence of major complications after implantation was 97.5% Authorized LP.¹
• EMBLEM S-ICD system-to-system communication success rate is 98.8% Authorized LP.²
• ATP success rate is 61.3%,³ No patient requested discontinuation of ATP or bradycardia pacing due to pain or discomfort.
• The pacing capture threshold (showing that the device is stably fixed within the heart) was ≤ 2.0 V at 0.4 milliseconds in 97.4% of patients.

“In this study, we saw excellent overall clinical performance of the mCRM system, including high communication success rates from S-ICD to leadless pacemaker, and low rates of major leadless pacemaker complications,” Reynolds KnopsMD, PhD, Department of Cardiology and ElectrophysiologyUMC Amsterdam, Amsterdam, The Netherlands. “These findings are noteworthy because of the high rate of successful communication and painless termination of spontaneous arrhythmic episodes, suggesting a potential escalation pathway for patients currently implanted with an S-ICD who require ATP or pacing .

The results of the APPRAISE ATP clinical trial were also presented at the 2024 Heart Rhythm Conference, “This is a prospective, randomized, multicenter study evaluating ATP as a treatment for discontinuation of primary prevention (PP) in patients (i.e., without spontaneous sustained ventricular tachycardia). primary strategy in patients with a history of ventricular tachycardia. The trial enrolled 2,626 patients with PP requiring an ICD at 134 centers worldwide and is the largest head-to-head trial of ATP in this patient population. In the study, patients were randomized in a 1:1 ratio to receive standard transvenous ICD therapy “ATP plus ICD shock to terminate ventricular tachycardia” or shock alone. After five years of follow-up, the data showed that only 1% of patients per year experienced a statistically significant but definitely small reduction in first all-cause shock. There were no significant differences between the two groups in shock load or the number of shocks patients experienced, and the vast majority of patients in the ATP plus shock group did not require ATP therapy.

“Together, data from the MODULAR ATP and APPRAISE ATP trials strengthen the promise of a breakthrough mCRM system, providing physicians with a clear path forward to deliver therapies that prevent sudden cardiac death and deliver ATP to the few patients who would benefit from it,” said Kenneth SteinMD, Senior Vice President and Global Chief Medical Officer, Boston Scientific Corporation. “These data suggest that doctors may have the opportunity to tailor treatment to patients’ individual circumstances, rather than putting all patients at risk with more invasive methods, such as putting wires into the heart or tunneling under the breastbone to provide services they may not otherwise have. Treatment required.

The company expects U.S. Food and Drug Administration The mCRM system will be approved in 2025. To learn more about the EBLEM MRI S-ICD System, please visit www.sicdsystem.com.

EMPOWER Limited Partner is a research device and is subject to the following restrictions us Legally restricted to research use only. It is not for sale. Some device references are for informational purposes only and are awaiting CE marking. Not applicable in European Economic Area.

PhD. Reynolds Knops is a paid consultant Boston Scientific Corporation. He has not received compensation in connection with this release.

about Boston Scientific Corporation
Boston Scientific Corporation Transforming lives through innovative medical technologies and improving the health of patients around the world. As a global medical technology leader for more than 40 years, we advance the life sciences by delivering a broad range of high-performance solutions that address unmet patient needs and reduce healthcare costs. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions.For more information, please visit www.bostonscientific.com and connect to LinkedIn and Xformerly Twitter.

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¹ Major complications were defined as any complications associated with Authorized LP or whose implantation procedure results in system modification, permanent loss of LP function, hospitalization, or death.
² During the communication test, the S-ICD attempted to command the LP to provide pacing at a rate of approximately 10 beats/minute faster than the patient’s native rhythm.
³ ATP success rate was defined as termination of ventricular arrhythmias.