EMBLEMTM S-ICD Automated Screening Tool

1. Theuns, D.A.M.J. et al. Evaluation of a High Pass Filter Designed to Reduce Over sensing in the S-ICD, HRS 2016; AB05-01 2. Moss A. et al. Reduction in Inappropriate Therapy and Mortality through ICD Programming, NEJM 2012; 367:2275-22833. Wilkoff B, et al. Strategic programming of detection and therapy parameters in implantable cardioverter-defi brillators reduces shocks

in primary prevention patients: results from the PREPARE (Primary Prevention Parameters Evaluation) study. JACC 2008; 52:541-550.4. Data on fi le at Boston Scientifi c, validation report DN-233335. Brisben, A.J., et al. A new algorithm to reduce inapppropriate therapy in the S-ICD system. J. Cardiovasc. Electrophysiol. Pp 1 – 7.6. Boersma, L. et al. Performance and outcomes in patients with the Subcutaneous Implantable Cardiac Defi brillator through Mid Term

Follow-Up: The EFFORTLESS Study HRS 20167. Data on fi le at Boston Scientifi c, System Algorithm Validation Report 11324748. EMBLEM S-ICD & EMBLEM MRI S-ICD User’s Manual, 359481-001, 2016.9. Priori SG, et al. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac

death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Eur Heart J 2015;36:2793- 2867.

10. Boersma, L. ICD from real life to the future: ICD innovations. ESC 201411. Cappato, R. “Are we ready for a paradigm shift?”. Europace 201512. Poole J and Gold M. Who Should Receive the Subcutaneous Implanted Defi brillator? The Subcutaneous Implantable Cardioverter

Defi brillator Should Be Considered in All ICD patients Who Do Not Require Pacing. Circulation: Arrhythmia and Electrophysiology. 2013; 6:1236-1245.

All cited trademarks are the property of their respective owners. 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 labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations. Information not intended for use in France.

CRM-444505-AA DEC2016 Printed in Germany by medicalvision.

www.bostonscientifi c.eu

© 2017 Boston Scientifi c Corporationor its affi liates. All rights reserved.DINCRM0953EA

ICD indication*

S-ICD unless…

…up to 80 %…up to 80 %6

Risk of infection

Non-suitable ECG

5-10 %5-10 %66

Pacing indication

~5 %~5 %6

Life expectancy

Sustained MVT

~5 %~5 %6

*non-CRT

EMBLEMTM S-ICD Automated Screening Tool

S-ICD should be consideredfor patients at risk of SCD unless …

9,10,11,12

1mm kürzer

*non-CRT*non-CRT*non-CRT*non-CRT*non-CRT

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Epicardial ICD

Transvenous ICD

Subcutaneous ICD (S-ICD)

# in bench test data *compared to 1st generation S-ICD ** as modelled with EFFORTLESS patient episodes

2nd generation

EMBLEM™

S-ICD

SMR8 – a morphology-based algorithm was demonstrated# to decrease TWOs by 30 – 40 %*4,5

SMART Pass Technology – decreases IAS due to TWOs by 82 %* to 3.8 %**1,4,9

EMBLEM™ MRIS-ICD

3rd generation

• Smaller, thinner, longer-lasting device*

• LATITUDE™ compatible8

• SMART Pass3

• MRI compatible8**

• AF Monitor™

SQRX

1st generation

EMBLEM™

S-ICD

2nd generation

EMBLEM™ MRIS-ICD

ImageReady

™ • ImageReady™ •

Imag

eRea

dy™

• Im

ageReady™

MR

FULL BODYSCAN

3rd generation Automated Screening Tool

• New EMBLEM Electrode• Electrode Delivery System (EDS)• 2-incision technique labelling• Inter-muscular labelling

The S-ICD was developed to provide a less invasive solution for patients at risk for Sudden Cardiac Arrest.

EMBLEM S-ICD Automated Screening Tool

in S-ICD patient screening andimproves the screening workfl ow.& How to obtain a successful screening

with the Automated Screening Tool

Developments, such as refi ning the S-ICD detection algorithms, have reduced Inappropriate Shock rates (IAS), which are now similar to TV-ICD IAS rates.1,2,3

Why screen patients for the S-ICD?1. To determine whether patients have a suitable signal for device sensing at implant. 2. To maximise system sensitivity and specifi city for rhythm identifi cation and therapy,

and to minimise risk of cardiac oversensing.

Available through the Zoom Programmer (3120)

Applies the Vector Select algorithm that is used by the S-ICD to sense the cardiac signal, and is designed to more closely represent S-ICD device performance.7

The S-ICD has gone through rapid and incremental refi nements in technology.

2002 2009 2017 Future2015 2015

Increaseseffi ciency

Decreasessubjectivity

How to obtain a with the

1. Place electrodes correctly

2. Click EMBLEM S-ICDAutomated Screening Tool

3. Verify a clean ECG

4. Run the Test: Supine & Standing.Print and / or export test data

5. Review and determineacceptable vectors***

Future developments:Modular CRM (mCRM) approach

** * At least one common ECG lead must PASS for all tested postures. At a minimum, Supine and Standing/Sitting postures must be tested8

in technology.

to 3.8 %

for device sensing at implant. for rhythm identifi cation and therapy,

for device sensing at implant. for rhythm identifi cation and therapy,

for device sensing at implant. for rhythm identifi cation and therapy,

to 3.8 %

for device sensing at implant. for rhythm identifi cation and therapy, for rhythm identifi cation and therapy,

for device sensing at implant. for device sensing at implant. for rhythm identifi cation and therapy,

for device sensing at implant. for rhythm identifi cation and therapy, for rhythm identifi cation and therapy, for rhythm identifi cation and therapy, for rhythm identifi cation and therapy, for rhythm identifi cation and therapy,

for device sensing at implant. for device sensing at implant. for device sensing at implant. for device sensing at implant. for rhythm identifi cation and therapy, for rhythm identifi cation and therapy, for rhythm identifi cation and therapy, for rhythm identifi cation and therapy,

for device sensing at implant. for device sensing at implant. for device sensing at implant. for device sensing at implant. for rhythm identifi cation and therapy, for rhythm identifi cation and therapy, for rhythm identifi cation and therapy, for rhythm identifi cation and therapy, for rhythm identifi cation and therapy, for rhythm identifi cation and therapy, for rhythm identifi cation and therapy, for rhythm identifi cation and therapy, for rhythm identifi cation and therapy, for rhythm identifi cation and therapy, for rhythm identifi cation and therapy, for rhythm identifi cation and therapy,

for device sensing at implant. for rhythm identifi cation and therapy, for rhythm identifi cation and therapy,

for device sensing at implant. for rhythm identifi cation and therapy,

for device sensing at implant. for rhythm identifi cation and therapy,

for device sensing at implant. for rhythm identifi cation and therapy,

1mm kürzer

GeneralDiagnosis:Screening Notes:

Pass - Primary

Results SummaryMedialLead Position

Mark AllAcceptable

Leads*

Morphologyconsistentbetween

postures?

OtherOtherOtherOtherStanding/Sitting

SupineLead

YesNo

OKOKPrimary(Lead-III)

YesNo

OKFAILSecondary(Lead-II)

YesNo

FAILFAILAlternate(Lead-I)

T_END*Minimum screening criteria: One lead must be OK in all tested postures.Check that morphology of the QRS complex is stable across postures.T_ENDNote:Special circumstances may present in which the physician may elect to proceed with the implantation of the S-ICD Systemdespite failing the screening process. In this case, careful attention should be applied to the device setup process of theS-ICD System as the risk of poor sensing and/or inappropriate shock is increased.

Clinician Signature:© 20162889 Software Version: ---Boston Scientific Corporation

or its affiliates. All rights reserved.Page 1 of 5

Report Created 02 Sep 2016 09:18ZOOM ® View™EMBLEM™ S-ICD Automated Screening Report

Patient 3Patient Name or ID10 Jul 1925Date Of Birth

Physician NameClinic NameMedical Record No.

Medial

Morphologyconsistentbetween

postures?

OtherOtherOtherOtherStanding/Sitting

YesYesYNo

OK

YesYesYNo

OK

YesYesYNo

FAILFAILF

ia: One lead must be OK in all tested postures.phology of the QRS complex is stable across postures.

y present in which the physician may elect to proceed with the implantation of the S-ICD Systemailing the screening process. In this case, careful attention should be applied to the device setup process of the

isk of poor sensing and/or inappropriate shock is increased.

Supine02 Sep 2016 07:55Result

OKPrimaryOKSecondaryOKAlternate

Notes

Clinician Signature:© 20162889 Software Version: ---Boston Scientific Corporation

or its affiliates. All rights reserved.Page 2 of 5

ZOOM ® View™02 Sep 2016 08:00EMBLEM™ S-ICD Automated Screening Report

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