EMBLEM™ S-ICD System
Subcutaneous Implantable Defibrillator
- 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.
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.
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
- Burke M, et al. Safety and Efficacy of a Subcutaneous Implantable-Defibrillator (S-ICD System US IDE Study). Late-Breaking Abstract Session. HRS 2012.
- Bardy, et. al. An Entirely Subcutaneous Implantable Cardioverter–Defibrillator. N Engl J Med 2010;363:36-44.
- van Rees JB et al. Implantation Related Complications of ICD and CRT-Ds Meta-analysis; JACC 2011;58:995-1000.
- Peterson PN et al. JAMA. 2013;309(19): 2025-2034
- 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.
- 2012 S-ICD Technology Survey conducted by Cameron Health Inc. Data on file.