EMBLEM™ S-ICD System

Subcutaneous Implantable Defibrillator

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Operational Excellence

Boston Scientific’s EMBLEM S-ICD System can be an important tool to help manage resources and improve workflow.

Key Resources

Directions for Use Patient Information Indications, Safety and Warnings
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The implantation of the EMBLEM S-ICD System can be done with little or no medical imaging
  • There is no requirement for fluoroscopy or other medical imaging during the surgical implant procedure, though it is recommended to use imaging equipment as needed to ensure proper placement

  • This results in reduced exposure to radiation and contrast dye during the EMBLEM S-ICD System implantation

  • This may present a new opportunity in how to manage your catheter lab schedule and future lab investment decisions

  • No medical imaging means that you have flexibility regarding where you perform the procedure in your facility

Allows predictability in the implant

Difficulties in achieving venous access during a transvenous ICD (TV-ICD) implant can prolong the procedure and occasionally result in failed ICD implantation.2 Implantation of transvenous leads can be difficult or even impossible for certain patients who have compromised or abnormal venous structures or mechanical heart valves. Additionally, the S-ICD reduces the possibility of complications related to the placement of transvenous leads including pneumothorax and perforation.

EMBLEM S-ICD System
The S-ICD System was designed to address certain acute and chronic challenges of existing transvenous ICDs including difficulties associated with central venous access, endocardial lead positioning and fixation.2 In a pooled analysis of the S-ICD data, S-ICD had lower acute major complications (Hematoma, lead or device mal-position or displacement, pneumothorax) than seen in TV-ICD studies (2% vs 3-5%).3-5
Early S-ICD System studies show that the procedure time (including device insertion and at least two induction and termination tests) among practitioners who completed at least three implantations was 55±23 minutes.2

Intuitive Programming at Implant and Efficient Follow-up for You and Your Team

The EMBLEM S-ICD System features sophisticated algorithms that require minimal programming for you and your team. Device programming and follow-up are designed for simplicity and efficiency.

EMBLEM Programmer

At the initial implant, the device performs an automatic setup, which will identify an optimal configuration

Enabling the Conditional Shock Zone (Dual-Zone) automatically turns on additional morphology discriminators that have been shown to reduce the incidence of inappropriate therapy6

Defibrillator threshold testing is performed through the programmer

No PSA measurements are required during implant

Follow-ups require no threshold testing

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Sources:

  1. Burke M, et al. Safety and Efficacy of a Subcutaneous Implantable-Defibrillator (S-ICD System US IDE Study). Late-Breaking Abstract Session. HRS 2012.
  2. Bardy, et. al. An Entirely Subcutaneous Implantable Cardioverter–Defibrillator.  N Engl J Med 2010;363:36-44.
  3. van Rees JB et al. Implantation Related Complications of ICD and CRT-Ds Meta-analysis; JACC 2011;58:995-1000.
  4. Peterson PN et al. JAMA. 2013;309(19): 2025-2034
  5. Burke MC et al. Pooled Analysis of the EFFORTLESS and IDE Registry. JACC 2015; online April 20th. This analysis included only S-ICD System Model 1010.
  6. 2012 S-ICD Technology Survey conducted by Cameron Health Inc. Data on file.

Referências

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