MODULAR ATP Study of the mCRM™ System Meets Primary Safety and Efficacy Endpoints
Rhea-AI Summary
Boston Scientific announced positive six-month results from the MODULAR ATP study of the mCRM System, which integrates the EMBLEM S-ICD and EMPOWER LP. The study met all safety and efficacy endpoints, showing a 97.5% major complication-free rate and a 98.8% communication success rate between devices. The ATP success rate was 61.3%, with no patients requesting therapy deactivation. The EMPOWER LP demonstrated stable device fixation. Findings were presented at Heart Rhythm 2024 and published in The New England Journal of Medicine. The APPRAISE ATP trial also supported the modular therapy approach, showing a small reduction in first all-cause shocks over five years in a large patient group. FDA approval is anticipated in 2025.
Positive
- MODULAR ATP study met all safety and efficacy endpoints.
- Major complication-free rate of 97.5% for EMPOWER LP.
- Communication success rate of 98.8% between EMBLEM S-ICD and EMPOWER LP.
- ATP success rate of 61.3% with no patient therapy deactivations due to discomfort.
- Pacing capture thresholds met in 97.4% of patients.
- Positive clinical performance suggests a potential upgrade pathway for patients needing ATP or pacing.
- Data indicates physicians can tailor therapy to patient needs, reducing the risks of more invasive procedures.
- FDA approval of the mCRM System anticipated in 2025.
Negative
- APPRAISE ATP trial showed only a small absolute reduction in first all-cause shocks (1% per year).
- Shock burden was not significantly different between trial arms.
- The vast majority of patients in the ATP-plus-shock arm did not require ATP therapy.
- EMPOWER LP is still an investigational device, not available for sale or in the European Economic Area.
News Market Reaction – BSX
On the day this news was published, BSX gained 0.95%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
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 EMPOWER LP as a standalone pacemaker, the trial evaluated the ability of the EMBLEM S-ICD System to successfully communicate a wireless request to the LP to deliver ATP therapy. 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 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. Reinoud Knops, M.D., Ph.D., Department of Cardiology and Electrophysiology, Amsterdam UMC,
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
"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 Kenneth Stein, M.D., senior vice president and global chief medical officer, Boston Scientific. "Instead of subjecting all patients to the risks of more invasive approaches, such as placing leads in the heart or tunneling 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."
The company anticipates
*The EMPOWER LP is an investigational device and limited by
**Dr. Reinoud Knops is a paid consultant of Boston Scientific Corporation. He has not been compensated in connection with this press release.
About Boston Scientific
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and connect on LinkedIn and X, formerly Twitter.
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1 Major complications defined as any complication related to the EMPOWER LP or its implantation procedure that results in system revision, permanent loss of LP function, hospitalization, or death.
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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SOURCE Boston Scientific Corporation
FAQ
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