CARDIOVASCULAR
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MR CONDITIONAL INFORMATION FOR RADIOLOGISTS

We offer MRI Ready (MR Conditional) products for cardiac pacing, defibrillation and monitoring.

Below please find scan details for our MRI Ready products, grouped by practice area.

MRI Ready devices are commercially available for use in select international markets.

 

CARDIAC RHYTHM MANAGEMENT AND ELECTROPHYSIOLOGY RESOURCES

MRI READY SCAN PARAMETERS PRODUCT SEARCH

Our look-up tool provides scan parameter information about our MRI Ready pacemakers and leads.

Use the tool:

PACEMAKERS

Some of our MRI Ready pacemakers have high-power scan capability, so you can use the best available diagnostic tools without worry. Those include cardiac scan sequences up to 4 W/kg and spinal and other thoracic scans.

 

 Clinician Checklist

DE |ES |IT

 MRI Ready Clinician Checklist

 Pacemaker MRI Summary Report PDF

 Pacemaker MRI Settings Alert

Our MRI Ready Products Eliminate Steps, Streamlining Workflow

How much more could you get done if you did not have to worry about reprogramming pacing devices before and after an MRI scan? With the St. Jude Medical MRI Activator™ handheld device, you can turn off and on pre-established MRI settings on all of our MRI Ready pacemakers. Less time and effort spent on pre- and post-scan device reprogramming. No more patient inconvenience; just a streamlined workflow.

The traditional workflow process for MRI patients
A streamlined workflow process for MRI patients
SJM Confirm™ Implantable Cardiac Monitors

The SJM Confirm™ implantable cardiac monitor (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 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 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 Confirm ICM produced a temperature rise of less than 3°C at a maximum MR system-reported whole-body-averaged SAR of 3.9 W/kg as displayed on the MR scanner console for 60 minutes of MR scanning in a 1.5 T 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 Confirm implantable cardiac monitor.

IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDs)

 MRI Scan Patient Checklist

 

Fortify Assura™ ICD

 

The Fortify Assura™ ICD allows full-body, 1.5T MRI scans that meet certain scan conditions, when combined with specific lead and lead lengths that are MR Conditional.*

  • Meets industry-standard MRI testing requirements
  • Capable of full body 1.5T MRI imaging scans

 

Ellipse™ ICD

 

The Ellipse™ ICD is built for the real world. We worked with physicians to determine what they wanted most from an ICD: patient safety and comfort. We turned those ideas into the Ellipse ICD. 

  • Small, physician-designed shape
  • Up to 36 J delivered energy
  • Tailored Therapy™ features
  • Wireless remote monitoring with Merlin@home™ Transmitter

Now MRI ready

The Ellipse ICD System allows full-body, 1.5T MRI scans* that meet certain scan conditions.

  • Meets industry-standard MRI testing requirements
  • Capable of full body 1.5T MRI imaging scans

HEART FAILURE MANAGEMENT RESOURCES

CardioMEMS™ HF System

Non-clinical testing demonstrated that the CardioMEMS™ PA sensor is MR Conditional. A patient with this device can be scanned safely, immediately after implantation under the following conditions:

  • Static magnetic field of 1.5 Tesla (T) or 3.0 T.
  • Maximum spatial gradient magnetic field of 720 Gauss/cm (7200 mT/m) or less.

In non-clinical testing, the CardioMEMS™ PA sensor produced the temperatures in the table below during MRI performed for 15 minutes of scanning (per pulse sequence) in the 1.5 T/64 MHz1 and 3 T/128 MHz2 MR systems. These temperature changes will not pose a hazard to the patient under the conditions indicated.

Table 2. MRI Related Heating

 

1.5 Tesla

3 Tesla

MR system reported whole body averaged SAR

2.9 W/kg

2.9 W/kg

Calorimetry measured values, whole body averaged SAR

2.1 W/kg

2.7 W/kg

Highest temperature change

1.9°C

2.3°C

MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the sensor. Selecting optimal MR imaging parameters to compensate for the presence of the sensor may be necessary. The maximum artifact size (as seen on the gradient echo pulse sequence) extends approximately 5 mm relative to the size and shape of the sensor.

Table 3. Artifact Information

Pulse sequence

T1-SE

T1-SE

GRE

GRE

Signal void size

305 mm2

34 mm2

645 mm2

101 mm2

Plane orientation

Parallel

Perpendicular

Parallel

Perpendicular

MULTIPOINT™ PACING PRODUCTS
Quadra Assura MP™ CRT-D and Quartet™ Quadripolar LV Lead

The Quadra Assura MP™ CRT-D and the Quartet™ Quadripolar LV lead allow full-body, 1.5T MRI scans* that meet certain scan conditions.

  • Meet industry-standard MRI testing requirements
  • Capable of full body 1.5T MRI imaging scans

 

REFERENCES

*See MRI Ready Systems Manual for device and lead combinations and associated MRI scan parameters.

**Indications, contraindications, warnings and precautions can be found in the Instructions for Use available by request or online at medical.abbott/manuals.

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