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MRI Eligibility

Designed for safety
InterStim™ SureScan™

SureScan™ technology expands MRI eligibility — allowing your patients to have better access.

   

GORD - Doctor and Patient

Why SureScanTM MRI technology matters?

Our proprietary SureScanTM lead technology for InterStimTM systems offers:

Safety

Proprietary tantalum braiding allows radiofrequency energy to be safely distributed from the MRI – ensuring heat is shared across the entire lead, not solely on the electrodes.

Quality

Increased strength and durability of the lead body with a continuous braided diameter design.‡ Single injection molding during manufacturing to remove bonded components. 

Control

The bent lead stylet and directional indicator are designed to:

  • Improve steering of lead tip to target10
  • Expedite implant procedures10
  • Maximize points of stimulation with lead lying along the nerve’s natural anatomy

Expanded eligibility

Proprietary SureScan™ technology allows patients with InterStim™ SureScan™ systems to get full-body* 1.5-and 3-T MRI scans, so you can bring life-changing results1,2,3 to an even wider range of people. 

Why is 3T MRI labeling important

3T MRI provides superior signal to noise ratio (SNR), which can result in improved image quality compared to 1.5T MRI imaging.11,12

If the MRI center has already upgraded to a 3T system, the patient will need an alternative if their device is not 3T eligible. By providing a 3T MRI eligibility to patients with out-of-range impedance, Medtronic ensures better MRI access.

Improved workflow

The SureScan™ MRI systems are designed to streamline MRI scans for patients, technicians and clinic staff.

No impedance check prior to scanning, which is designed to reduce repeat visits and to help patients save time.8

MRI mode can be easily activated on a smart programmer.6

All Medtronic InterStim™ MRI systems with SureScan™ technology, within the same geography, have the same MRI conditions.8

 

 

Full-body
1.5-T & 3-T
MRI Scans*

20+ years
of full-body
MRI research

1.2 million4,5
scanning
scenarios

10 million5
simulated
patient scans

MRI accessibility comparison

  Medtronic InterStim™ systems†,8
Full-body MRI eligibility for low impedance​
3T full-body MRI eligibility for out-of-range impedance​
No impedance check required prior to full-body MRI​
Digital display clearly confirms MRI mode activation
Full-body scans allowed within first level controlled operating mode​
18.6% of patients may have an impedance issue during the life of an implant

What is impedance?

Impedance is a measurement of the effective resistance of an electrical circuit. An out-of-range impedance can indicate a source of electrical abnormality with the lead or connections. Low impedances can result from a short circuit (can occur from a crush injury or fluid leak). High impedance can indicate an open circuit (can occur from a lead fracture or loose connection).

Two lab engineers studying device

Unique design

Dedicated engineers, scientists, and technicians working together at our MRI Centre of Excellence and MRI testing lab developed proprietary SureScan™ technology.
This unique design allows patients receiving sacral neuromodulation (SNM) therapy to have an MRI scan with confidence.

Full-body 1.5T and 3T MRI scans with SureScan™ technology

SureScan™ MRI technology provides MRI technicians with a simple, convenient, and streamlined workflow.

  • No impedance checks required prior to MRI scans
  • Scans allowed even if patients have out-of-range impedances
  • MRI mode is easy to activate or deactivate on a smart programmer without clinician or Medtronic interaction
  • Digital display for clear confirmation of MRI mode activation
SureScan lead

SureScan™ lead has proprietary tantalum braiding that allows radiofrequency energy to be safely distributed from the MRI.

Broadest MRI access for your sacral neuromodulation patients8,9

Experience matters. With more than 20 years+ of MRI research, 10 million simulated patient scans, and more than 1.2 million unique scanning scenarios, Medtronic SureScan™ MRI systems offer broad MRI access.4,5

Activating MRI mode on an InterStim™ system

Patients should place the InterStim™ system in MRI mode before the MRI scan and outside of the MRI scanner room. When MRI mode is activated with the smart programmer, stimulation is turned off and the “MRI mode activated” screen appears, showing MRI scan eligibility.

MRI screen modes

MRI
Eligibility

Get the details on specific MRI compatibilty for neuromodulation therapies.

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* Under certain conditions; see approved labeling for details. Patients with InterStim™ SureScan™ MRI leads only. 

† Within each geography

‡ Medtronic data on file. Characterization Test Report. NDHF1536-162039v2.0 Mechanical Overview Summary – SNM Lead Model 978A1, 978B1

1

Siegel. S., Noblett, K, MangelJ. et al. “Five Year Follow-up Results of a Prospective. Multicenter Study in Overactive Bladder Subjects Treated with Sacral Neuromodulation.” J Urol.2018;199(1), 229-236

2

Hull T. Giese C, Wexner SD, et al. Long-term durability of sacral nerve stimulation therapy for chronic fecal in incontinence. Dis Colon Rectum. 2013:56(2):234-245

3

Van Kerrebroeck et al. J Urol. 2007 Nov;178(5):2029-34

4

Combination of body model. MRI manufacturer, implant location, lead length, & scan type

5

Medtronic data on file — result of animal studies combined with lab data, computational modeling, and statistical methods.NDHF1559-186167v4.0, NDHF1567- 186848v2.0

6

MRI SureScan™ technical manuals on www.medtronic.com/manuals

7

Perrouin-Verbe MA et al. Device programming, MRI utilization and safety of sacral neuromodulation through 24 months in a global post-market study. Eur Urol. 2024;85(Supplement 1):S178]

8

Medtronic MRI Guidelines for InterStim™ systems, M980291A032 Rev A

9

Axonics MRI guidelines EU, 23-Sep-2022 Revision: 110-0069-001Rp

10

Medtronic data on file. System Design Document. M951822A Bent Stylet Report

11

Stankiewicz JM, Glanz BI, Healy BC, et al. Brain MRI lesion load at 1.5T and 3T versus clinical status in multiple sclerosis. J Neuroimaging. April 2011;21(2):e50-e56. 3).

12

Kamada K, Kakeda S, Ohnari N, Moriya J, Sato T, Korogi Y. Signal intensity of motor and sensory cortices on T2-weighted and FLAIR images: intraindividual comparison of 1.5T and 3T MRI. Eur Radiol. December 2008;18(12):2949-2955.

13

Fascelli M, Rueb J, Derisavifard S, et al. Mp31-06 Prevalence of Abnormal Impedance in Sacral Neuromodulation Device and Implication for Practice. J Urol 2020;203 (Supplement 4): e476-e477.

The material on this website should not be considered the exclusive source of information, it does not replace or supersede information contained in the device manual(s).

Please note that the intended use of a product may vary depending on geographical approvals. See the device manual(s) for detailed information regarding the intended use, the (implant) procedure, indications, contraindications, warnings, precautions, and potential adverse events.

For a MRI compatible device(s), consult the MRI information in the device manual(s) before performing a MRI. If a device is eligible for eIFU usage, instructions for use can be found at Medtronic’s website manuals.medtronic.com. Manuals can be viewed using a current version of any major internet browser.

For best results, use Adobe Acrobat® Reader with the browser. Medtronic products placed on European markets bear the CE mark and the UKCA mark (if applicable). For any further information, contact your local Medtronic representative.