Dark-themed S-ICD and heart anatomical visual

EMBLEM™ MRI
S-ICD
Future-Ready Cardiac Care

Proven Protection. Personalised Care.

Modular CRM evidence visual with S-ICD

About the mCRM™ System

Modular therapy represents a paradigm shifting in treating CRM patients. The Boston Scientific Modular CRM System consists of the extrathoracically-positioned EMBLEM S-ICD and EMPOWER Leadless Pacemaker that are designed to work together to co-ordinate treatment. Providing individualised, tailored therapy, as and when the patient needs it, while avoiding more invasive approaches.

Why Modular CRM Theraphy?

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 Leadless Pacemaker, 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.

Icons showing modular CRM benefits and adaptability

>75%

of VR ICD patients have no pacing indication at implant1,2

∽2%

of ICD patients develop a pacing need each year3

How Does the mCRM™ System Work?4

1. When the EMBLEM S-ICD senses an episode of tachycardia, it triggers the EMPOWER Leadless Pacemaker 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.


Example of mCRM™ Therapy

Tjong FVY, et al. HRS 2016.

Watch the system in action as the EMBLEM™ S-ICD and EMPOWER™ LP coordinate during an mCRM™ therapy sequence.


mCRM System Components

Image of an EMBLEM S-ICD device

EMBLEM™ S-ICD: A Low-Risk Solution for SCD

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

• Preserves the vasculature

• Remains outside the ribcage, never touching the heart

Image of an EMPOWER device

EMPOWER Leadless Pacemaker (LP)*

The EMPOWER Leadless Pacemaker 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

Explore more:

MODULAR ATP Study

Learn about the MODULAR ATP Clinical Study design, primary effectiveness and safety endpoints, timelines and more.

Study Eligibility

Explore patient inclusion and exclusion criteria and find resources to help you refer study candidates.

Training Site

Explore education and training resources for the EMPOWER™ Modular Pacing System.

*EMPOWER™ component pending CE Mark. Not available for sale.

References:

1. Gasparini, M, Lunati, MG, Proclemer, A, et al. Long Detection Programming in Single-Chamber Defibrillators Reduces Unnecessary Therapies and Mortality. JACC Clin Electrophysiol. 2017;3(11):1275–1282.

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

3. Botto GL, Forleo GB, Capucci A, , et al. The Italian subcutaneous implantable cardioverter-defibrillator survey: S-ICD, why not? Europace. 2017;19(11):1826–1832.

4. Boston Scientific. Data on file.

ATP, antitachycardia pacing; CRM, cardiac rhythm management; ICD, implantable cardioverter defibrillator; LP, leadless pacemaker; MVT, monomorphic ventricular tachycardia; S-ICD, subcutaneous ICD.


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.