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Medtronic Receives FDA Approval for Expanded MRI Labeling of InterStim™ SureScan™ MRI Leads
"I'm pleased to see medical technology for SNM patients continue to improve," said
The revised MRI labeling provides more options to patients and physicians than the labeling of the other SNM system on the market:
- For MRI scanning facilities with B1+rms technology — the gold standard in MRI scanning technology — the new SureScan MRI lead scanning parameters1 increases B1+rms for 1.5 Tesla scans from 3.0 µT to 4.0 µT, and 3 Tesla scans from 1.3 µT to 2.0µT. B1+rms is the gold standard because it is consistent if a patient has multiple MRI scans across different facilities.2 The competitor's MRI labeling does not specify parameters for 1.5T scans with B1+rms technology.
- The new Medtronic scanning parameters1 increases SAR limits for 1.5 Tesla scans from 0.5 W/kg to 2.0 W/kg; and for 3 Tesla scans from 0.5 W/kg to 1.4 W/kg.
- The new labeling also decreases wait time from 60 minutes to 5 minutes for maximum duration scans (30 minutes).
These guideline updates are in addition to the benefit already provided by SureScan MRI technology that impedance checks prior to an MRI scan are not required, providing more efficiency in patient care versus the other SNM system on the market.
"Our updated InterStim SureScan MRI labeling means the best choice in SNM therapy keeps getting better," said
About InterStim SureScan MRI Technology
SureScan MRI technology is a known and trusted brand by MRI technicians. Built on more than 19 years of full-body MRI research, 10 million simulated patient scans, and more than 1.2 million unique scanning scenarios, Medtronic SureScan MRI systems prioritize patient safety.3
About Sacral Neuromodulation
Sacral neuromodulation (SNM) uses a small device to send electrical impulses to the sacral nerves located in the lower back to improve bladder and bowel control. Unlike oral medications that target the muscular component of bladder control, SNM offers control of symptoms through direct modulation of the nerve activity, normalizing the communication between the bladder and the brain.4,5
More than 37 million adults in
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the
- For the inferior to C7 vertebra.
- Reference Manual for Magnetic Resonance Safety, Implants and Devices: 2020 Edition,
Frank G. Shellock, PhD
- Medtronic data on file.
- Leng WW, Morrisroe SN. Sacral nerve stimulation for the overactive bladder. Urol Clin N Am. 2006;33:491-501.
- Kenefick NJ, Emmanuel A, Nicholls RJ. Effect of sacral nerve stimulation on autonomic nerve function.
British Journal of Surgery. 2003;90:1256-1260.
- Stewart WF, et al. Prevalence and burden of overactive bladder in
the United States. World J Urol. 2003 May;20(6):327-336. United Nations, Department of Economic and Social Affairs, Population Division (2011). World Population Prospects: The 2010 Revision, CD-ROM Edition.
- Whitehead WE, Borrud L, Goode PS, et al. Pelvic floor disorders network. Fecal incontinence in US adults: epidemiology and risk factors. Gastroenterology. 2009;137: 512-517.
- United States Quick Facts.
United States Census BureauWeb site. Available at: https://www.census.gov/quickfacts/table/ PST045215/00. Accessed July 19, 2016.
- Dmochowski RR, Newman DK. Impact of overactive bladder on women in
the United States: results of a national survey. Current Medical Researchand Opinion. 2007;23:65-76. Leede Research, "Views on OAB: A Study for the National Association of Continence." December 16, 2015.
- Yu YF, Nichol MB, Yu AP, et al. Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid Program. Value in Health. 2005;8(4)495-505.
- Yeaw J, Benner JS, Walt JG, Sian S, Smith DB, et al. J Manag Care Pharm. 2009;15(9):728-740.
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