s-icd implant technique and

S-ICD Implant Technique and Best Practices

CRM-1000402-AA ©2021 Boston Scientific Corporation or its affiliates. All rights reserved.

Table of Contents

• Evolution of Technology and Implant Experience

• Pre-Implant Considerations

• Draping and Patient Prep

• S-ICD System Placement

• Initial Incision for Device Pocket

• The Intermuscular Technique

• Xiphoid Incision

• Lateral Tunnel

• Anchoring Electrode at Xiphoid

• Superior Tunnel

• Implanting the Pulse Generator

• Securing the Pulse Generator

• DFT Testing

• Device Replacement

• Appendix: X-Ray Practice

• Appendix: Replacement Case Study

2CRM-1000402-AA ©2021 Boston Scientific Corporation or its affiliates. All rights reserved.

Technology Advancement and Evolution of Implant Technique

3

2012 2013 2014 2015 2016 2018 2019 2021+2017

Dual Zone Programming

Use of conditional zone reduces inappropriate shocks and unnecessary therapy

SMR-8A new double detection algorithm was introduced with SMR-8

3rd Generation SMART Pass, AF Monitor, MRI compatible

Model 3300 ProgrammerAST 2.0 and S-ICD app

Implant OptimizationsIntroduction of the S-ICD System by Cameron Health

2001- 2008 2010 20112009

1st

Generation

Acquisition of Cameron Health

Automated Screening, Electrode #3501, 2 Incision labelling, Intermuscular labelling, Electrode Delivery System (EDS)

AHA/ACC/HRS GuidelinesClass I and IIa

2nd

GenerationSmaller, thinner,longer-lasting device,LATITUDE™ compatible

Proof of ConceptElectrode configuration (2001 – 2004), DFT (2004 – 2005), First chronic implant (2006 -2008)

2020

Future DevelopmentsmCRM™ Modular Therapy Systems

Overview of Pre-Implant Considerations

1. General patient health and co-morbidities

2. Consideration of patient risk of infection

3. Patient activity levels• Considerations for both screening and implant

4. Body size assessment• Weight, height, BMI (high and low)• Soft tissue considerations• Chest anatomy• Chest size• Consider taking posterior-anterior and lateral

chest x-rays

5. Anesthesia options and pain management• Pre, peri, and post-operative

6. Medication• Anticoagulation and antiplatelet treatment• Considerations with amiodarone and other

antiarrhythmic drugs (particularly related to high DFT/difficulty inducing VF)

• Prophylactic antibiotic treatment

4CRM-1000402-AA ©2021 Boston Scientific Corporation or its affiliates. All rights reserved.*Note: Individual practices and specific patient situations should be considered.

Pre-Implant Considerations: Patient Screening

5

It is important to collect the surface ECG in the location that represents the intended position of the implanted S-ICD system. If a non-standard S-ICD system subcutaneous electrode or pulse generator placement is desired, the surface ECG electrode locations should be modified accordingly.

Preparing skin prior to placing surface electrodes:• Remove hair• Clean skin using a non-alcohol wipe and/or skip prep gel

Importance of ECG Electrode RL:The ECG Electrode RL is placed on the opposite side of the patient, preferably on a bony structure, to serve as the grounding or reference electrode. This is best practice to ensure stable baseline.

“At least one common ECG lead must be deemed acceptable for all tested postures. At a minimum, supine and standing/sitting postures must be tested.”1

RA

LALLBest Practices

Labeling


Draping and Patient Prep: Placement of Electrode Pads

6

Electrode pads should be placed:

• Front below right clavicle (more rightward than customary, to allow for a larger sterile field anteriorly).

• Back below the left scapula on the back of the patient.

b

a

b

a


Draping and Patient Prep: Arm Placement

Ensure arm is positioned at an angle not greater than 60 with the palm up during implant.2

Ideal position of the arm for DFT. Attention should be taken not to strap the arm too tightly during DFT. To help prevent injury, the arm can be unstrapped and lowered to the patient’s side during DFT with the thumb positioned on top.2

7

b

a

c

a b

c


Draping and Patient Prep: Placement of Sterile Drapes

8

Placement of sterile drapes are used to build the surgical window for the placement of the S-ICD system:

• A drape is placed halfway between the xiphoid and the umbilical line

• A drape is placed along the left side where patient’s body meets surgical table, running superiorly from the axilla to inferiorly halfway between the xiphoid and umbilical line

• A drape is placed no closer than 2cm to the right of the patient’s midline extending superiorly to the clavicle and inferiorly halfway between the umbilical line and the xiphoid

• A drape is placed extending from the drape placed across the neck to the drape running along the patient’s left side1

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c d

b

a

c

d


Complete S-ICD Patient Draping

9

Video (~3 min)

Click here or scan the QR code to go to the Draping and Patient Prep Best Practices module on EDUCARE.

Scroll down the page for a short video of prep and drape best practices with Dr. Knops.

CRM-1000402-AA ©2021 Boston Scientific Corporation or its affiliates. All rights reserved.Note: Patient has already been marked in this image. Refer to subsequent slides for marking.

https://sicdtraining.com/Module2/#/lessons/LYzIUQ4rzoFL5XxZQqs1Fh0hTHYcN6EI

S-ICD System Placement: Use of Landmarks and X-Ray

10

In the PA view, the sensing rings are parallel and about 1cm from the sternal midline. The pulse generator is at the mid-axillary line.

a

b

EMBLEMTM S-ICD Electrode (Model 3501)

a

b

The pulse generator is implanted at the mid-axillary line. The proximal electrode is placed near the xiphoid; the distal electrode tip in the superior sternum. The proximal electrode is to be placed vertical and parallel to the sternum (not horizontal) to ensure best position for primary sensing vector.

For appropriate sensing, the distal electrode should avoid the pectoralis muscle.

a

ba

Best Practices

Tip


S-ICD System Placement: Use of Landmarks for Marking

11

When marking, ensure that the sub xyphoid incision is on bone. On large patients or patients with prominent breast tissue this can be challenging so verify that you are above the xyphoid prior to making an incision.

Best Practices


S-ICD System Placement: Use of Landmarks for Marking

12

Video (~3 min)

Click here or scan the QR code to watch a 3 minute video on marking.


https://player.vimeo.com/video/502804178#t=4m35s

Initial Incision for S-ICD Device Pocket

13

An incision is made along the inframammary crease, just above the anticipated position of the pulse generator, to avoid post procedural mechanical stress on the wound.2

If this position is not considered optimal i.e., concerns about cutting along the line of the breast in women, an incision may be made above the mid-axillary line.

Some physicians recommend that following Langer’s lines may help with healing and reduction in scarring.

Injection of local anaesthesia into incision area is common practice for post-procedural pain relief.• Cauterize vessels to ensure a dry pocket.• Ensure the whole length of wound is opened to the same depth.• Test pocket size with device and ensure it is not too tight (to reduce risk of erosion and pain) or too big (to avoid room for

twiddling).

Best Practices


Initial Incision for S-ICD Device Pocket

14

Video (~3 min)

Click here or scan the QR code to watch a 3 minute video on the initial incision for device pocket.



The Intermuscular Technique

15

Caudal Cranial

Serratus Anterior

Latissimus Dorsi

The intermuscular technique may be used to reduce DFT (particularly in larger body habitus patients), to improve patient comfort or cosmetic appearance (particularly for low BMI patients), or for repositioning of the device following infection of the subcutaneous pocket.

Benefits of the Intermuscular Technique2-7

Optimal position for DFT and impedance measurements

Reduced risk of pocket complications and device migration

Consistency in implant technique

Patient comfort: device is protected by the muscle layer

Cosmetic outcomes: can is less visible

Best Practices

Video (~1 min)

Click here or scan the QR code to watch a 1 minute video on the pocket formation for the intermuscular technique.

https://sicdtraining.com/wp-content/uploads/2020/06/CRM-828405-AB_Intermuscular_Pocket_Formation_Video-PSST1.mp4

Subcutaneous vs. Intermuscular Device Position

16

Subcutaneous Device Position Intermuscular Device Position


Intermuscular Technique Positions Device Between Serratus Anterior and Latissimus Dorsi

17Images provided by Joachim Winter, MD, Professor of Surgery Heinrich-Heine-University Duesseldorf and Senior Consultant Augusta Hospital Duesseldorf.

Make an incision along the inframammary crease. The pocket is created by blunt dissection between the serratus anterior and latissimus dorsi muscles (muscle fibers are not cut), with the majority of the pulse generator placed behind the latissimus dorsi. This area is generally free from blood vessels. From the incision, the subcutaneous tissue is dissected directly down to the fascia, the contour of the chest wall is followed to create the pocket. The pulse generator is secured to the fascia of the serratus anterior.4-7


Intermuscular Technique: Low BMI Male and Low BMI Female


Xiphoid Incision – Width and Depth

19

Images from cadaver

When cutting down at the xiphoid, it is important to ensure that the tissue is dissected down to the fascia. A wider than 2cm incision at the xiphoid may be necessary to allow access to the fascia in order to secure the lead.

“Size and orientation of the incision may vary at the physician’s discretion based on the patient’s body habitus.”1

Best Practices

Labeling

Video (~2 min)

Click here or scan the QR code to watch a 2 minute video on the xiphoid incision.



Creating the Lateral Tunnel

20

1

2

3

Step 1: Use Lateral Tunneling Tool: insert distal tip at xiphoid incision and tunnel laterally until distal tip emerges at the pocket incision. Verify locking collar is securely fastened to pre-loaded sheath.11

Step 2: Disengage locking collar and remove Tunneling Tool from sheath while applying forward pressure to hub of sheath to stabilize it within the tunnel. 11

Step 3: Starting from distal end of sheath at pocket incision, push distal tip of electrode through sheath until entire defibrillation coil has passed through sheath and emerged at xiphoid.Hold proximal end of electrode at pocket to stabilize and remove sheath by pulling out through xiphoid incision.11


Creating the Lateral Tunnel

21

Video (~7 min)

Click here or scan the QR code to watch a 7 minute video on creating the lateral tunnel.



Anchoring Electrode at XiphoidAnchor the suture sleeve to the deep fascia using at least 2 of the 4 suture grooves. It can be anchored before or after sternal tunneling.

Based on physician preference, the suture sleeve may be anchored in a horizontal, vertical, or curved orientation.


Creating the Superior Tunnel

23

Determine intended position of distal tip of electrode.

The intended position of the distal tip of the electrode is approximately 14 cm superior to the xiphoid incision.

Ensure length of the superior tunnel will accommodate the portion of the electrode from distal tip to suture sleeve without buckling or curving of defibrillation coil.11

1

Video (~7 min)

Click here or scan the QR code to watch a 7 minute video on creating the superior tunnel.




24

Use shorter, Superior Tunneling Tool to create superior tunnel.

Verify locking collar is securely fastened to pre-loaded sheath.

Insert distal tip of Tunneling Tool into xiphoid incision between adipose and fascial plane.

Tunnel towards the superior position, in parallel to sternal midline, staying below adipose tissue, and as close to the deep fascia as possible.11

2



25

3

4

5

Disengage sheath from locking collar by turning collar counter-clockwise. Remove tool from sheath, while applying forward pressure to the hub of sheath to stabilize it in the tunnel.11

Crack the hub of the sheath. 11

Starting at the xiphoid incision, advance distal tip of electrode through sheath until the distal sensing electrode reaches the superior position. Palpate electrode tip to confirm it is correctly positioned. 11

Stabilize electrode at the xiphoid incision and/or at the tip to ensure it remains in position during sheath removal. Peel sheath to remove. 11

6




• When creating the superior tunnel, it is critical to ensure the tunnel is deep on the fascia to ensure proper positioning of and sensing by the electrode.

• “To ensure adequate lead position and to avoid defibrillation test issues caused by high shock-lead impedance, the curvature of the sternum should be followed by forcing the tip of the EDS directly over the bone tissue of sternum.“2

• The superior tunnel extends to the level of the 2nd intercostal space (manubrio-sternal junction).

• Put saline in the sheath prior to inserting the electrode to help reduce air entrapment and provide good electrical contact between the coil and surrounding tissue. Additionally, after cracking the sheath, massage the tunnel from the sternal notch down to the incision to ensure there is no trapped air.

Best Practices

Implanting the Pulse Generator: Connecting Electrode to the Device

27CRM XXXX-XXXX

1

2

3

Gently insert torque wrench (provided with PG) into the setscrew by passing it through the pre-slit center depression of the seal plug at a 90° angle.

With torque wrench in place, fully insert the electrode terminal into the electrode port.

Tighten setscrew by slowly turning the torque wrench clockwise, until it ratchets.

Remove the torque wrench.

Perform “tug test” by applying gentle traction to the electrode to ensure a secure connection.

4

5

Remember “Click, Remove, Tug” (a mnemonic for this is C.R.T). These steps aim to prevent the tearing of the seal plug, as this may allow rapid ingress of body fluids which can lead to over-sensing of cardiac signals.

Tip

Video (~2 min)

Click here or scan the QR code to watch a 2 minute video on connecting the electrode to the device.


Securing Pulse Generator into the Pocket

28

1. Attach a non-absorbable suture to at least one suture hole on the device header.

2. Insert device into intermuscular pocket, with any excess electrode placed underneath device.

3. Secure device to fascial plane covering the serratus anterior muscle.

4. Close incisions and perform Automatic Setup and final device testing.

5. Ensure all air is expelled before closing. Video (~2 min)

Click here or scan the QR code to watch a 2 minute video on positioning the pulse generator into the pocket.

1

2

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5


Securing Pulse Generator into the Pocket

29

• Avoid acute bends in the electrode.

• Avoid air entrapment and ensure good tissue contact with the implanted electrode by flushing all incisions with sterile saline solution and firmly massaging each incision and down length of the electrode to expel any residual air out through the incisions prior to closing.

• Consider fluoroscopy to check electrode position prior to closure.

• Consider performing 10J shock to measure high voltage shocking lead impedance before conversion testing. The higher the impedance, the lower the conversion success rate.

Best Practices

DFT Testing Best Practices

30

Refer to previous slides for the appropriate arm position for DFT testing.

System placement should reflect the original screening capturing the ventricular mass between the can and the coil.16

If commanding shock reveals high impedance, coil positioning should be assessed for adequacy. This finding may indicate that there is fat under the coil of the electrode, which should be positioned on the fascia.14

• Even small amounts of fat under the coil (5mm) will increase the shocking lead impedance and significantly increase the required energy to convert the patient.

• Shocking lead impedance would also be increased if the device is not in a good contact with the tissue in the pocket.

• Based on the data from the IDE study, impedance <90 ohms results in >90% success. Conversely if impedance is >110 ohms, success drops to 70%.9

If defibrillation fails at 65J, fluoroscopy is recommended to evaluate the position of the can and coil to ensure there is no underlying fat. Also, ensure that the can is not anterior, which raises the DFT but does not increase impedance.16

1

2

3

4

Video (~30 min)

Click here or scan the QR code to watch a 30 minute video on DFT and impedance.



Impact of Anterior Can Position on DFT Testing

31

Posterior, standard, and mid-anterior positions result in DFT below the 80J that the S-ICD delivers. Anterior position (+8 cm) or a full can width more anterior than standard position, results in a DFT above 100J which is above the 80J the S-ICD delivers. Note that while device placement shows DFT increases as the can is placed more anterior, device placement doesn't impact the shocking lead impedance. 8

22 J 29 J

64 J

135 J

Posterior(-4 cm)

Standard(0 cm)

Mid-Anterior(+4 cm)

Anterior(+8 cm)

DFT

, J

Max Output = 80J


Impact of Underlying Fat on Impedance and DFT Testing

32

Due to the high resistance of fat, fat under the electrode or can has large impacts on DFT by increasing the shocking lead impedance.8

78 Ω 83 Ω 81 Ω 78 Ω 83 Ω

117 Ω144 Ω

105 Ω

163 Ω

Posterior Can(-4 cm)

Standard Can(0 cm)

Mid-AnteriorCan

(+4 cm)

Anterior Can(+8 cm)

Sub-Coil Fat(0 mm)

Sub-Coil Fat(5 mm)

Sub-Coil Fat(10 mm)

Sub-Can Fat(20 mm)

Sub-Coil andSub-Can Fat

(10 mm and 20mm)


Device Positioning8

33

OptimalAnterior Posterior

Inferior SuperiorOptimal


Electrode Positioning8

34



S-ICD Spontaneous Conversion Success

35

IDE Data illustrated that one key factor in determining S-ICD conversion success is the high voltage impedance measurement.9

Lower impedance enables higher effective defibrillation currents and lower energies.10

Based on the data from the IDE study, impedance <90 ohms results in >90% success. Conversely if impedance is >110 ohms, success drops to 70%.9

TipUNTOUCHED11

N = 1,111(Enrolled 2015 - 2018)

IDE14

N = 321(Enrolled 2009)

PAS 1 Year12

N = 1,637(Enrolled 2013 - 2015)

EFFORTLESS 3 Year13

N = 985 (Enrolled 2009 - 2013)

98.4%

100%

100%

97.4%

92.1%

88.5%

91.3%

92.2%

First Shock Final Shock

Over a decade of clinical data have consistently demonstrated high spontaneous conversion rates for the S-ICD. The S-ICD has comparable success rates in treating spontaneous VT/VF when compared to studies with TV-ICD and even higher success rates in some instances.


Device Replacement Considerations

36

Verify if patient body habitus has changed significantly (weight gain or weight loss). Has weight change affected the S-ICD can, electrode position, shocking impedance or sensing?

Ask patient if present device location is comfortable. If not, consider if device location can be modified during replacement to improve patient comfort.

Compare electrode and device position to original implant. If movement has occurred, consider X-ray (PA and Lateral) to confirm. Is there need to revise the system position during the replacement? Ensure that electrode has not moved and is positioned away from the site of incision.

Alternative device positions (intermuscular) may be appropriate considerations to reduce DFT (particularly in larger body habitus patients), for patient comfort or cosmetic appearance, or for reposition of the device following infection of the subcutaneous pocket.“Depending on patient body habitus and anatomy, the physician may choose to position the device between the serratus anterior muscle and the latissimus dorsi muscle, in which case the device should be secured to the musculature. Creating the device pocket can be accomplished by making an incision along the inframammary crease.”1

1

2

3

4


DFT Testing and Device Replacement

37

Labeling for the S-ICD currently states, “Defibrillation testing is recommended at implant and at replacement procedures to confirm the ability of the S-ICD System to sense and convert VF.”1 However, a physician may choose not to perform VF conversion testing based on their clinical judgment.

Labeling

IDE Data illustrated that one key factor in determining S-ICD conversion success is the high voltage impedance measurement.

To obtain an impedance measurement, a commanded shock, typically 10J, may be used. Note that the IDE data indicates that impedance <90 ohms results in >90% success. Conversely if impedance is >110 ohms, success drops to 70%. 1,9

Tip


38

Appendix• X-Ray Practice• S-ICD Replacement Case Study


X-Ray Practice


Review: Intermuscular Placement is Optimal for DFT and Impedance Measurements8

40

Impact of Anterior Can PositionAnterior position (+8 cm) or a full can width more anterior than standard position, results in DFT above 100J which is above the 80J the S-ICD delivers.

78 Ω 83 Ω 81 Ω 78 Ω 83 Ω117 Ω 144 Ω

105 Ω163 Ω

Posterior Can(-4 cm)

Standard Can(0 cm)

Mid-AnteriorCan

(+4 cm)

Anterior Can(+8 cm)

Sub-Coil Fat(0 mm)

Sub-Coil Fat(5 mm)

Sub-Coil Fat(10 mm)

Sub-Can Fat(20 mm)

Sub-Coil andSub-Can Fat

(10 mm and 20mm)

22 J 29 J64 J

135 J

Posterior(-4 cm)

Standard(0 cm)

Mid-Anterior(+4 cm)

Anterior(+8 cm)

Impact of Underlying FatDue to the high resistance of fat, fat under the electrode or can has large impacts on DFT by increasing the shocking lead impedance.

NOTE: The source for the DFT model is of a 64 year old male, 100 kg, 180 cm tall, with a DFT of 29J and impedance of 83 ohms.


Device Positioning8

41

OptimalAnterior Posterior



Electrode Positioning8

42



Troubleshooting Failed Conversion Testing with S-ICD• If commanding shock reveals high impedance, coil positioning should be assessed for adequacy. This

finding may indicate that there is fat under the coil of the electrode, which should be positioned on the fascia.14

• Even small amounts of fat under the coil (5mm) will increase the shocking lead impedance and significantly increase the required energy to convert the patient.

• Shocking lead impedance would also be increased if the device is not in a good contact with the tissue in the pocket.

• Based on the data from the IDE study, impedance <90 ohms results in >90% success. Conversely if impedance is >110 ohms, success drops to 70%.9

• If defibrillation fails at 65J, fluoroscopy is recommended to evaluate the position of the can and coil to ensure there is no underlying fat. Also, ensure that the can is not anterior, which raises the DFT but does not increase impedance.16


Example: Troubleshooting Failed Conversion Testing with S-ICD

44

Successful DFT: 80 OhmsFailed DFT: 114 Ohms

Brouwer et al, JACC-EP 2016:2(1);89-96CRM-1000402-AA ©2021 Boston Scientific Corporation or its affiliates. All rights reserved.

X-Ray Practice: Patient #1

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What are the key takeaways for the electrode and device placement?



46

Answer:• Electrode on fascia and

straight up on sternum• Device placement is mid-

lateral



47




48

Answer:• Electrode too lateral and

electrode tip too superficial• Device placement is

anterior



49

Explain the failure to induce VF for this patient.



50

Answer:• Electrode and device placement

inferior. Note how shocking vector passes through diaphragm and stomach which increases impedance and lowers shock efficacy.



51




52

Answer:• Electrode placement is appropriate• Device placement is somewhat anterior



53




54

Answer:• Electrode placement is

appropriate• Device placement is

anterior


S-ICD REPLACEMENT CASE STUDY:CHRONIC ANTERIORLY PLACED SUBCUTANEOUS ICD WITH ELEVATED DFTs REPOSITIONED TO POSTERIOR INTERMUSCULAR POSITION DURING DEVICE REPLACEMENT FOR ERI

Scott J. Greenberg, M.D.Cardiac Electrophysiologist, Woodlands North Houston Heart Center Assistant Professor, Baylor College of Medicine

CRM-1000402-AA ©2021 Boston Scientific Corporation or its affiliates. All rights reserved. 55

Clinical History• 72 year old male patient with history of hypertrophic cardiomyopathy who initially had S/ICD (first

generation Model 1010) implanted in 2014 for primary prevention of sudden cardiac death by outside EP

• Since implantation, patient had not received therapy for ventricular arrhythmias.• The device reached ERI in July 2020 and recommendations were to replace device within

28 days of reaching ERI.


Initial Implant: 2014


Device Replacement: ERI July 2020At replacement due to ERI, patient’s history of elevated DFT’s was considered. Prior device wasin an anterior position; plan was to implant device in more posterior, intermuscular location.

Heist, K. et al. Determinants of Subcutaneous Implantable Cardioverter-defibrillator Efficacy: A Computer Modeling Study. JACC Clinical 2017

22 J 29 J

64 J

135 J

Posterior(-4 cm)

Standard(0 cm)

Mid-Anterior(+4 cm)

Anterior(+8 cm)

DFT

, J

Max Output = 80J

58

Pre-procedure Patient Marking

• Fluoroscopic imaging with a demo device was performed to select a target location for the new S-ICD and the location was marked.

• Opening the original incision (1) would make it difficult to place device in posterior location.

• The new incision site (2) was selected to provide access to both the chronic device anchoring sutures and to the intermuscular space between the anterior serratus and the latissimus dorsi muscles.

• The target location for the new device (3) was an entire can width (7cm) more posterior than the original S-ICD. The amount of available accessory lead length was considered in reaching the new target location.


Defibrillation Threshold Testing Results

New Posterior (+Superior) Location

65 Joules, Reversed Polarity, 107 ohms, Success (1st attempt)


Defibrillation Threshold Testing Results

New Posterior (+Superior) Location

65 Joules, Reversed Polarity, 107 ohms, Success (1st attempt)

Original Anterior Location

80 Joules, Reversed Polarity, 98 ohms, Success (4th attempt)


Patient Follow-up

• Incision closed with 2.0 VICRYL, 4.0 MONOCRYL

• Patient went home the same day of device change-out

• Pain well-controlled with intermuscular implantation; incision healing well

• Patient notes that the new device location is much more comfortable than original device location


References1. 359481-001 EN Europe 2015-11, EMBLEMTM MRI S-ICD Pulse Generator2. Brouwer, T.F. et al. Implantation of the subcutaneous implantable cardioverter defibrillator: an evaluation of 4 implantation techniques. Circ Arrhythm Electrophysiol. 2017;

10.1161/CIRCEP.116.0046633. Migliore, F. et al. Intermuscular two-incision technique for subcutaneous implantable cardioverter defibrillator implantation: results from a multicenter registry. PACE, 2017; 00:1 – 8.4. Droghetti, A. et al. Totally submuscular implantation of subcutaneous implantable cardioverter defibrillator: a safe and effective solution for obese or oversized patients. Clinical Case Reports, 20165. Ferrari, P. et al. Intermuscular pocket for subcutaneous implantable cardioverter defibrillator: Single-center experience. J. Arrhythmia (2016).6. .Subzposh, F. et al. Successful Implant of the Subcutaneous Implantable Cardioverter Defibrillator in Patients with Low Body Mass Index. JACC. 2014; 63:127. Winter, J. et al., Intermuscular technique for implantation of the subcutaneous implantable cardioverter defibrillator: long-term performance and complications. Europace, 2016, doi:10.1093/

europace/euw2978. Heist, K. et al. Determinants of Subcutaneous Implantable Cardioverter-defibrillator Efficacy: A Computer Modeling Study. JACC Clinical Electrophysiology, 20179. Weiss, R. et al. Safety and Efficacy of a Totally Subcutaneous Implantable-Cardioverter Defibrillator. Circulation. 2013;128:944-953.10. Amin, A.K. et al. Factors Associated With High-Voltage Impedance and Subcutaneous Implantable Defibrillator Ventricular Fibrillation Conversion Success. Circ Arrhythm Electrophysiol.

2019;12:e006665.11. 359316-001 EU1 2014-06, 4711 EMBLEMTM S-ICD Electrode Insertion Tool12. Gold M. et al., UNTOUCHED Trial Primary Results. Heart Rhythm Society Late Breaking Clinical Trials LBCT-02 2020.13. Burke MC, et al. 1-Year Prospective Evaluation of Clinical Outcomes and Shocks. JACC: Clinical Electrophysiology. 2020.14. Boersma, L et al., The EFFORTLESS Study. J Am Coll Cardiol, 2017. 70(7): p. 830-84115. Weiss, R, et al. Safety and Efficacy of a Totally Subcutaneous Implantable-Cardioverter Defibrillator. Circulation. 2013.16. Utilizing Evidence to Ensure Successful Defibrillation with the S-ICD System, CRM-387912-AA, EN US 2016-04


EMBLEMTM MRI S-ICD SystemINDICATIONS FOR USE The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.

CONTRAINDICATIONS Unipolar stimulation and impedance-based features are contraindicated for use with the S-ICD System.

WARNINGS Concomitant use of the S-ICD System and implanted electromechanical devices (for example implantable neuromodulation/neurostimulation systems, ventricular assist device (VAD), or implantable insulin pump or drug pump) can result in interactions that could compromise the function of the S-ICD, the co-implanted device, or both. The S-ICD is intended as lifesaving therapy and should be seen as priority in the decision and evaluation of concomitant system implants over non-lifesaving applications. Electromagnetic (EMI) or therapy delivery from the co-implanted device can interfere with S-ICD sensing and/or rate assessment, resulting in inappropriate therapy or failure to deliver therapy when needed. In addition, a shock from the S-ICD pulse generator could damage the co-implanted device and/or compromise its functionality. Verify sensing configuration, operation modes, surgical considerations and existing placement of all involved devices prior to any co-implant. To help prevent undesirable interactions, test the S-ICD system when used in combination with the co-implanted device, and consider the potential effect of a shock on the co-implanted device. Induction testing is recommended to ensure appropriate detection and time to therapy for the S-ICD and appropriate post-shock operation of the co-implanted device. Failure to ensure appropriate detection and time to therapy delivery of the S-ICD system could result in patient injury or death. Following completion of the interaction testing, thorough follow-up evaluation of all co-implanted devices should be performed to ensure that device functions have not been compromised. If operational settings of the co-implanted devices change or if patient conditions changes which may affect S-ICD sensing and therapy performance, re-evaluation of the co-implanted devices may be required. Do not expose a patient with an implanted S-ICD System to diathermy. EMBLEM S-ICD devices are considered MR Conditional. Unless all MRI Conditions of Use are met, MRI scanning of the patient does not meet MR Conditional requirements for the implanted system. The Programmer is MR Unsafe and must remain outside the MRI site Zone III. During MRI Protection Mode the Tachycardia therapy is suspended. MRI scanning after ERI status has been reach may lead to premature batter depletion, a shortened device replacement window, or sudden loss of therapy. The Beeper may no longer be usable following an MRI scan.

Do not expose a patient with an implanted S-ICD System to diathermy. EMBLEM S-ICD devices are considered MR Conditional. Unless all MRI Conditions of Use are met, MRI scanning of the patient does not meet MR Conditional requirements for the implanted system. The Programmer is MR Unsafe and must remain outside the MRI site Zone III. During MRI Protection Mode the Tachycardia therapy is suspended. MRI scanning after ERI status has been reach may lead to premature batter depletion, a shortened device replacement window, or sudden loss of therapy. The Beeper may no longer be usable following an MRI scan. The pulse generator may be more susceptible to low frequency electromagnetic interference at induced signals greater than 80 uV. The S-ICD System has not been evaluated for pediatric use.

PRECAUTIONS For specific information on precautions, refer to the following sections of the product labeling: clinical considerations, sterilization and storage, implantation, device programming, environmental and medical therapy hazards, hospital and medical environments, home and occupational environments, follow up testing, explant and disposal, supplemental precautionary information.

POTENTIAL ADVERSE EVENTS Potential adverse events related to implantation of the S-ICD System may include, but are not limited to, the following: Acceleration/induction of atrial or ventricular arrhythmia, adverse reaction to induction testing, allergic/adverse reaction to system or medication, bleeding, conductor fracture, cyst formation, death, delayed therapy delivery, discomfort or prolonged healing of incision, electrode deformation and/or breakage, electrode insulation failure, erosion/extrusion, failure to deliver therapy, fever, hematoma/seroma, hemothorax, improper electrode connection to the device, inability to communicate with the device, inability to defibrillate or pace, inappropriate post shock pacing, inappropriate shock delivery, infection, injury to or pain in upper extremity, including clavicle, shoulder and arm, keloid formation, migration or dislodgement, muscle/nerve stimulation, nerve damage, pneumothorax, post-shock/post-pace discomfort, premature battery depletion, random component failures, stroke, subcutaneous emphysema, surgical revision or replacement of the system, syncope, tissue redness, irritation, numbness or necrosis.

Patients who receive an S-ICD System may develop psychological disorders that include, but are not limited to, the following: depression/ anxiety, fear of device malfunction, fear of shocks, phantom shocks.

92436235 (Rev. A)

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.


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