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SJM Confirm™ Implantable Cardiac Monitor

Continuous Cardiac Monitoring To Streamline Diagnosis Of Unexplained Syncope

The SJM Confirm Implantable Cardiac Monitor (ICM) captures valuable information to assist physicians in diagnosing the causes of abnormal heart rhythms.

SJM Confirm Implantable Cardiac Monitor
Overview

Syncope is a common and disabling condition that is associated with an increased risk of morbidity and mortality and remains difficult to diagnose.1 Medical literature reports that a diagnosis is possible in up to 90% of patients with syncope using an implantable monitor.2

The SJM Confirm ICM is an integrated system consisting of the implantable device used for automatic-triggered event storage, the handheld, external device called the Patient Activator used for patient-triggered event storage, and the Merlin® Patient Care System, which provides communication, data retrieval and programming capabilities.

Streamline Implantation with Minimally Invasive Device

  • Small size – at 6.5 cc – the smallest ICM on the market
  • Excellent longevity – three years
  • Subcutaneous electrodes for simplified procedure

Improve Signal Detection

  • Proven SenseAbility® technology designed for accurate sensing over a wide range of signals
  • Detection inhibitors for noise response and activity response

Customize and Prioritize Data Storage Options

  • Compatibility with Merlin Patient Care System (PCS)
  • Patient-triggered activation option for EGM storage
  • Additional programming options – tachycardia, bradycardia, asystole
  • 48 minutes of stored electrograms (147 episodes)
  • Data storage options for flexibility

Receive Vital Information through Extensive Data Reports

  • Comprehensive diagnostic data to assist in patient management
  • Transtelephonic monitoring for timely and accurate data transmission

Round-the-clock, 24/7, Transtelephonic Monitoring (TTM)

24/7 Remote monitoring is available through an exclusive agreement between St. Jude Medical and EquiMed Corporation* (a TTM service provider with 15 years of experience), offering:

Clinics:
  • Efficiency and convenience
  • Professionally interpreted reports that can be used in EHR
  • Immediate results available if necessary
  • Zero cost for service
Patients:
  • Live interaction with nurses (RNs) or certified cardiac technician (CCTs)
  • Immediate evaluation of patient activated events
  • More timely review of auto triggered events

MR Conditional

The SJM Confirm ICM DM2100 is conditionally safe for use in the MRI environment when used in accordance to the instructions in the user manual. Patients with newly implanted or previously implanted devices can now undergo MR scanning when following specific scanning conditions.

These conditions include:

  • Closed bore-cylindrical magnet
  • Static magnetic field strength of 1.5 Tesla (T) only
  • Maximum gradient slew rate 200 T/m/s per axis
  • Whole body Specific Absorption Rate (SAR) less than or equal to 2.0 W/kg
  • The uninterrupted duration of active scanning (when radio frequency (RF) and gradients are on) over the chest during MRI must not exceed 60 minutes
  • Confirmation of absence of other contraindicated implantable devices and/or leads, including abandoned leads, lead extenders and lead adaptors.

In non-clinical testing, the St. Jude Medical MR Conditional SJM Confirm ICM produced a temperature rise of less than 3°C at a maximum MR system-reported whole body averaged specific absorption rate (SAR) of 3.9 W/kg as displayed on the MR scanner console for 60 minutes of MR scanning in a 1.5T closed bore MR scanner (manufacturer Philips, model Intera 1.5, Software version: 9.5.2).

For additional information, including contraindications and potential adverse events please refer to the SJM Confirm ICM User’s Manual. It is important to read the information in the MRI Procedure section of the user manual before conducting an MRI scan on a patient with an implanted SJM MR Conditional SJM Confirm implantable cardiac monitor.


References

* For questions regarding 24/7 remote TTM follow-up, contact EquiMed directly: (phone) 1-800-451-7470; (e-mail) sales@equimedcorp.com, or (online) http://equimedcorp.com/.
1 Kapoor WN. Syncope. N Engl J Med 2000: 343: 1856-61.
2 Krahn AD, Klein GJ, Yee R et al. Use of an extended monitoring strategy in patients with problematic syncope. Circulation 1999; 99: 406-10.

Tech Specs

SJM™ Confirm™ Implantable Cardiac Monitor (ICM)

Ordering Information   View Catalog   

Reorder Number Description
DM2100 SJM Confirm ICM Model DM2100
DM2100A External Patient Activator Model DM2100A

Indications, Safety & Warnings
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Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

 

Last Updated: April 22, 2013