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 indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for other cardiac arrhythmias.
The SJM Confirm ICM, Model DM2102, is also indicated for patients who have been previously diagnosed.
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 reports provide a quick and accurate summary of heart rate, assisting physicians in their diagnosis and treatment of the patient’s condition. Reports include:
- AF burden up to 18 months
- Episodal diagnostics for auto-trigger events
- Episode duration
- Episode count
- Episode date/time stamp
- Heart rate histogram
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:
- Efficiency and convenience
- Professionally interpreted reports that can be used in EHR
- Immediate results available if necessary
- Zero cost for service
- Live interaction with nurses (RNs) or certified cardiac technician (CCTs)
- Immediate evaluation of patient activated events
- More timely review of auto triggered events
The SJM Confirm ICM DM2102 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.