EMBLEM™ MRI S-ICD System

Subcutaneous Implantable Defibrillator

S-ICD clinical data

Explore clinical study and real-world data on inappropriate shock rates, complication rates and more. Plus, learn about the prospective, randomized, head-to-head, clinical trials comparing S-ICD to TV-ICD.

PRAETORIAN XL Trial

The PRAETORIAN XL clinical trial was a 4-year extension of the PRAETORIAN Trial.¹ The trial reconsented 528 patients from the original PRAETORIAN enrollment for a total follow-up of eight years to evaluate the superiority of the S-ICD to TV-ICD with respect to the composite primary endpoint of major and minor device-related complications.¹

Key Resources

Directions for Use Patient Information Indications, Safety and Warnings

EDUCATION & TRAINING

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MODULAR ATP trial: Safety and efficacy of the mCRM™ system

Pivotal 6-month results from the first modular pacemaker-defibrillator system with wireless communication. The trial evaluated the safety, effectiveness, and performance of the Modular CRM (mCRM™) System* and the EMPOWER™ Leadless Pacemaker (LP).*

*Caution: Investigational device. Limited by US law to investigational use only. Not available for sale.

APPRAISE ATP trial: ATP plus shock vs. shock-only

Largest prospective randomized trial of ATP and transvenous ICD therapy in primary prevention patients. The study enrolled 2,626 primary prevention ICD indicated patients at 134 centers in North America, Europe, and Asia.¹¹

ATLAS Trial: Lead-related complication rates

ATLAS is the first prospective randomized controlled trial where the primary objective was to evaluate lead-related complication rates between the S-ICD and single chamber TV-ICD devices at six months after implant. Full results were published in 2022.

PRAETORIAN: S-ICD vs. TV-ICD

PRAETORIAN is the first prospective, randomized, head-to-head, non-inferiority clinical trial that compares S-ICD to TV-ICD. The trial followed 850 patients at 40 centers across Europe and the United States. Full results were published in 2020.

Analysis of the UNTOUCHED study

Hypothesis

The incidence of inappropriate shocks in primary prevention, LVEF ≤ 35% patients will be non-inferior to the rate in transvenous ICD patients with similar programming observed in MADIT-RIT Arms B and C.

Study Design

Follow-up for 18 months
Device programming with a conditional zone of 200 bpm and a shock zone of 250 bpm
Primary endpoint of inappropriate shock-free rate at 18 months
Secondary endpoints of all cause shock-free rate at 18 months and system and procedure complications at 30 days

Key Takeaways

1. In the UNTOUCHED study a subsequent sub-analysis demonstrated that the inappropriate shock rate with SMART Pass On was 1.8% at 1 year for EMBLEM™ S-ICDs. This is the lowest reported inappropriate shock rate for S-ICD, despite a cohort with more left ventricular dysfunction and heart failure.^2,3

Bar chart on prior S-ICD, untouched, and TV-ICD.

2. The appropriate shock rate of 5.7% over 18 months was low with a high conversion success of 98.4%, similar to that reported with TV-ICD trials.²

Data on S-ICD conversion rates and TV-ICD conversion rates.

3. Complication rates remain very low (95.8% complication free rate at 30 days, 92.7% at 18 months, and no systemic infections), despite enrolling a sicker patient population.²

95.8% 30 day complication free rate, 92.7% 18 month complication free rate, and 0 systemic infections.

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TV-ICD lead complications in the real world

The transvenous lead is the most common source of complications in a TV-ICD system. Data from over 40,000 patients from the OptumLabs Data Warehouse demonstrated that the incidence of mechanical and infectious complications of transvenous leads over long-term follow-up is much higher in the real world than in clinical studies.

3-4% of patients with TV-ICD suffer lead malfunctions in the first year of implant¹⁰

About 25% mechanical failure rate for TV-ICD at 10 years¹⁰

4% infection rate for TV-ICD at 10 years¹⁰

Year from implant vs. freedom from complication for ICD infection, CRT-D infection, ICD mechanical, and CRT-D mechanical.

Kaplan-Meier plot of lead revision associated with a diagnosis of infection or mechanical complication for patients with an implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator.