EMBLEM™ MRI S-ICD System

Why S-ICD Therapy

Clinical Data

EMBLEM S-ICD System

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Implant Procedure

INSIGHT™ Technology

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Automated Screening Tool

Implant Procedure

The EMBLEM MRI S-ICD has been built upon the excellent clinical performance of the world’s first subcutaneous ICD; providing protection for patients at risk for sudden cardiac death (SCD) while leaving the heart and vasculature untouched.

Entirely SUBCUTANEOUS ICD

The S-ICD system was designed to ensure simplicity and ease of implantation for a reliable and consistent system implant.

Key Resources

EDUCARE online education Directions for Use EMBLEM MRI Spec Sheet Indications, Safety & Warnings
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Optimised implant technique

The 2-Incision Technique is an alternative technique to the 3-Incision Technique, that:

May reduce procedure time due to elimination of the superior parasternal incision

“Pairwise comparison of implantation techniques demonstrated that the 2-incision technique with the pulse generator in the subcutaneous position was significantly shorter in procedure duration than the other 3 implant techniques”1

Improves Cosmetic Outcome for Patients

  • Elimination of scar improving cosmetic outcome
  • Removing superior incision as a site of potential discomfort2

Device Positioning and Patient Prep

The S-ICD System is designed to be positioned using anatomical landmarks 
Mark the intended position of the implanted system components and/or incisions prior to the procedure using anatomical landmarks and/or fluoroscopy
Patient Prep and Drape is the same as the 3-incision technique
Ensure arm is positioned at an angle not greater than 60° with the palm up during implant

Two Incision Implant Technique with Electrode Delivery System

(Please see EMBLEM/EMBLEM MRI Manual for full implant instructions)

Before implant, record a 3-lead surface ECG to assess the appropriateness of surface signals that correlate with device detection.

Animation of the S-ICD Two Incision Implant Technique, showing how the new Electrode Delivery System (model 4712).
Optimised S-ICD implant
 
Discover resources on training and implant technique

Electrode Delivery System (EDS) 4712

EDS is designed for use with the 2-incision technique*, to provide consistency and efficiency at implant.3

EDS consists of 2 Tunnelling Tools with pre-loaded sheaths.

EDS consists of 2 Tunnelling Tools with pre-loaded sheaths:

  • Pre-loaded sheaths are appropriately sized for Tunnelling Tool length
  • Diameter of rod, and tapering at end of sheath is designed to prevent sheath kinking
  • Dedicated Superior Tunnelling Tool for 2-incision technique (pre-loaded 14 cm sheath)
  • Standard length Lateral Tunnelling Tool for sheath delivery of electrode (pre-loaded 21 cm sheath)
*The Lateral tunnelling tool can also be used when implanting with the 3-IT, following the removal of the pre-loaded sheath.

Intermuscular Technique

With the intermuscular technique, a pocket is created between the Serratus anterior and Latissimus dorsi muscles, with the majority of the pulse generator placed behind the Latissimus dorsi.
With the intermuscular technique, a pocket is created between the Serratus anterior and Latissimus dorsi muscles.
The majority of the pulse generator placed behind the Latissimus dorsi.
Intermuscular device placement is particularly beneficial in low and high BMI patients.

Benefits of intermuscular device positioning highlighted in literature4-8:

  • Optimal position for DFT and impedance measurements  (dorsal/posterior, under adipose tissue)
  • Reduced risk of pocket complications (erosion and infection)
  • Reduced device migration
  • Patient comfort: device is protected by muscle layer
  • Cosmetic outcomes: can is less visible

Low BMI (19 % fat) female patient.
Device placed in an intermuscular position

Images courtesy of Prof. Jürgen Kuschyk, University Hospital Mannheim.

Optimal S-ICD Placement

Post-implant X-rays show optimal placement of the pulse generator and subcutaneous electrode.

Note: This image shows the placement of the first generation S-ICD system in a patient. Device location recommendations do not change from the S-ICD System to the EMBLEM MRI S-ICD.

Excellent Cosmetic Outcome

The pulse generator’s discrete pocket placement offers excellent aesthetic results. Once implanted, the EMBLEM MRI S-ICD System is designed to not limit range of motion and most patients are able to resume normal daily activity shortly after the procedure.
Results from cases studies are not necessarily predictive of results in other cases.  Results in other cases may vary

 
Top

1. Brouwer TF, Miller MA, Quast ABE, Palaniswamy C, Dukkipati SR, Reddy V, Wilde AA, Willner JM, Knops RE. Implantation of the subcutaneous implantable cardioverter-defibrillator: an evaluation of 4 implantation techniques. Circ Arrhythm Electrophysiol. 2017; 10:e004663. doi: 10.1161/CIRCEP.116.004663.
2. Knops RE, Olde Nordkamp LR, de Groot JR, Wilde AA. Two-incision technique for implantation of the subcutaneous implantable cardio-verter-defibrillator. Heart Rhythm. 2013; 10:1240-1243. doi: 10.1016/j.hrthm.2013.05.016.
3. EMBLEM™ S-ICD Electrode Delivery System Manual: 360210-001 EN Europe 2017-01.
4. 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/euw297.
5. 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. 2016; doi: 10.1002/ccr3.652.
6. 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.116.004663.
7. Kondo, Y. et al. Successful intermuscular implantation of subcutaneous implantable cardioverter defibrillator in a Japanese patient with pectus excavatum. Journal of Arrhythmia. 2016; https://dx.doi.org/10.1016/j.joa.2016.04.005.
8. Migliore, F. et al. Intermuscular Two-Incision Technique for Subcutaneous Implantable Cardioverter Defibrillator Implantation: Results from a Multicenter Registry. Pace. 2016; doi: 10.1111/pace.12987.

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