Main image of with a Heart surrounded by an EMBLEM and a EMPOWER devices

EMBLEM™ S-ICD MODULAR ATP

Proven Protection. Personalised Care.

Modular CRM evidence visual with S-ICD

MODULAR ATP Study1

Single-Group Study: Integration of the Subcutaneous ICD (S-ICD) and the EMPOWER™ Leadless Pacemaker (LP)

A global, prospective, non-randomised study evaluating the safety, performance and effectiveness of the modular Cardiac Rhythm Management (mCRM™) System, integrating the EMPOWER™ LP with the S-ICD.

Patient Population¹

•Total: N=293

•6-month cohort: n=162

•Completed 6-month follow-up: n=151


Key Results

Icon: 97.5% major complication-free rate

major complication-free rate

for EMPOWER™ LP, exceeding the performance goal of 86%.

Icon: 98.8% successful device communication

successful communication

between EMPOWER™ LP and S-ICD, exceeding the performance goal of 88%.

Icon: Pacing capture threshold exceeding 97%

pacing capture thresholds (PCTs)

≤2.0 V at a 0.4 ms pulse width,* exceeding the performance goal of 80%.

Conclusion

The EMPOWER™ LP was successfully implanted in all patients and, when integrated with the S-ICD, exceeded all predefined performance goals.

Explore more evidence:


*PCTs across patients were 0.56±0.49 V.1

Reference:

1. Knops RLM, Roberts PR, Roberts PR, et al. A Modular Communicative Leadless Pacing-Defibrillator System. N Engl J Med. 2024;391(15):1402–1412.


ICD, implantable cardioverter defibrillator; LP, leadless pacemaker; mCRM, modular cardiac rhythm management; ms, millisecond; PCT, pacing capture threshold; S-ICD, subcutaneous ICD; V, volt.


CAUTION:
The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device. or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.