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EMBLEM™ S-ICD System

Subcutaneous Implantable Defibrillator

Modular CRM (mCRM™) System*

Modular therapy represents a paradigm shift that could change what’s possible for CRM patients. The mCRM system from Boston Scientific consists of two devices that are designed to work together to coordinate therapy: the EMBLEM™ S-ICD and the EMPOWER™ Leadless Pacemaker (LP). Instead of subjecting all patients to the risks of more invasive approaches to provide therapies that they might not require, the mCRM System provides an unique alternative to tailor therapy to the individual patient's needs.

*Caution: Investigational device. Limited by US law to investigational use only. Not available for sale. 

Key Resources

EMBLEM S-ICD Indications, Safety and Warnings
View MODULAR ATP Trial Results
Request More Information

Request More Information
 

Why mCRM therapy?

Most ICD-indicated patients don’t have a pacing indication or known benefit from anti-tachycardia pacing (ATP). Yet with transvenous (TV) devices, all patients are exposed to the risks of transvenous leads. By combining the EMBLEM S-ICD and EMPOWER LP, mCRM therapy is designed to reduce the risk of TV leads while providing the option to pace or receive ATP for those who need it.
75%+ no pacing indication.

NO PACING INDICATION

More than 75% of VR ICD Patients Have No Pacing Indication at Implant1,2
2 times TV-ICD device extractions.

TV-ICD DEVICE EXTRACTIONS

2X More Device Extractions for Infection with TV-ICD than S-ICD3
About 2% pacing need.

PACING NEED

Approximately 2% of ICD Patients Develop a Pacing Need Annually4
 

Fewer lead-related complications seen in the PRAETORIAN trial3

The EMBLEM S-ICD leaves the vasculature untouched, thereby reducing the risk of acute and future complications associated with transvenous leads.

In the first prospective randomized head-to-head trial comparing the performance of S-ICD and TV-ICD, data showed that TV-ICD patients experienced more than four times as many lead-related complications as S-ICD patients.3

See More Trial Data

Bar chart showing lead-related complications for TV-ICD were 6.6% compared to 1.4% for S-ICD.

EMPOWER™ LP procedure videos

Video: Implant Procedure Fluoroscopy.

Implant Procedure Fluoroscopy Video

Implant Procedure Animation.

Implant Procedure Animation

Retrieval Procedure Animation.

Retrieval Procedure Animation

How mCRM therapy works

1. When the EMBLEM S-ICD senses an episode of tachycardia, it triggers the EMPOWER LP to provide ATP therapy, which may stop the tachycardia and reset the heart to a normal rhythm.

2. The EMBLEM S-ICD continuously monitors for the result of the ATP therapy.

a. If the ATP successfully terminated the tachycardia and returned the heart to a normal rhythm, the EMBLEM S-ICD will continue monitoring and no shock will be delivered.
b. If the ATP did not terminate the tachycardia, the EMBLEM S-ICD will deliver shock therapy.

Video: Coordinated therapy between the EMBLEM S-ICD and EMPOWER Leadless Pacemaker during a mCRM therapy sequence.

Example of mCRM Therapy

(Tjong, F.V.Y., et al. HRS 2016)

Watch the video to see the coordinated therapy between the EMBLEM S-ICD and EMPOWER LP during a mCRM therapy sequence.

 
MODULAR ATP Trial. See the data.
 

mCRM system components

EMBLEM S-ICD System, Model A219.

EMBLEM S-ICD

The only extrathoracic implantable defibrillator that provides protection from both sudden cardiac death and the risks and complications associated with transvenous leads. 

  • Eliminates potential for vascular injury, transvenous lead insertion complications, lead-associated tricuspid regurgitation, mechanically induced pro-arrhythmia, and transvenous lead failure and associated extraction risk
  • Reduces risk of systemic infection
  • Preserves the vasculature
  • Remains outside the ribcage, never touching the heart
EMPOWER Leadless Pacemaker.

EMPOWER LP*

The EMPOWER LP is designed to be paired with S-ICD to provide pacing or ATP therapies at the time they are needed.

  • ATP when commanded by a paired S-ICD
  • Delivery system with inner extendable shaft
  • 20.7 F delivery catheter
  • Dedicated retrieval catheter
  • Rate response via accelerometer
  • > 10 Year average longevity expected when used primarily for ATP therapy as part of an mCRM System

Are You a Clinical Site Investigator?

Explore education and training resources for the EMPOWER™ LP.
Go to Training Site
MODULAR ATP trial

MODULAR ATP trial

Learn about the MODULAR ATP clinical trial design, primary effectiveness and safety endpoints, timelines and more.

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Study eligibility

Trial eligibility

Explore patient inclusion and exclusion criteria.

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Pre-clinical Data

Pre-clinical data

See the pre-clinical data evaluating the use of mCRM technology in animal subjects.

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All EMBLEM S-ICDs can be upgraded and paired with EMPOWER Leadless Pacemakers

 *Caution: Investigational Device. Limited by US law to investigational use only. Not available for sale.

Products shown for informational purposes only. Not meant as a promotion or offer for sale. Certain components are pending CE Mark. Not available for sale in the European Economic Area (EEA).

References

1. Gasparini, M, Lunati, MG, Proclemer, A, et al., Long Detection Programming in Single-Chamber Defibrillators Reduces Unnecessary Therapies and Mortality. JACC: Clinical Electrophysiology, 2017.

2. Data on VR devices from LATITUDE Boston Scientific data on file.

3. Knops R. et al., A Randomized Trial of Subcutaneous versus Transvenous Defibrillator Therapy: The PRAETORIAN Trial. Heart Rhythm Society Late Breaking Clinical Trials LBCT-01 2020.

4. Botto, GL. The Italian subcutaneous implantable cardioverter-defibrillator survey: S-ICD, why not? EUROPACE. Dec 2016.

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