U.S. markets closed
  • S&P 500

    4,266.49
    +24.65 (+0.58%)
     
  • Dow 30

    34,196.82
    +322.58 (+0.95%)
     
  • Nasdaq

    14,369.71
    +97.98 (+0.69%)
     
  • Russell 2000

    2,333.62
    +30.15 (+1.31%)
     
  • Crude Oil

    73.23
    -0.07 (-0.10%)
     
  • Gold

    1,775.20
    -1.50 (-0.08%)
     
  • Silver

    26.00
    -0.05 (-0.21%)
     
  • EUR/USD

    1.1935
    0.0000 (-0.00%)
     
  • 10-Yr Bond

    1.4870
    0.0000 (0.00%)
     
  • GBP/USD

    1.3921
    -0.0000 (-0.00%)
     
  • USD/JPY

    110.8800
    +0.0450 (+0.04%)
     
  • BTC-USD

    34,756.46
    +1,315.59 (+3.93%)
     
  • CMC Crypto 200

    837.58
    +50.96 (+6.48%)
     
  • FTSE 100

    7,109.97
    +35.91 (+0.51%)
     
  • Nikkei 225

    28,875.23
    +0.34 (+0.00%)
     

FDA Approves Expanded MRI labeling For Medtronic's Sacral Neuromodulation Systems

  • Oops!
    Something went wrong.
    Please try again later.
·1 min read
  • Oops!
    Something went wrong.
    Please try again later.
  • The FDA has approved expanded MRI labeling of Medtronic plc's (NYSE: MDT) InterStim II and InterStim Micro sacral neuromodulation (SNM) systems that use SureScan MRI leads. The updated MRI Guidelines allow for a broader range of MRI scan parameters and a shorter wait time between MRI scans.

  • InterStim Micro is a small rechargeable device to deliver SNM therapy and is used for treating overactive bladder, fecal incontinence, and non-obstructive urinary retention. The InterStim SureScan MRI leads are used with InterStim Micro and with the recharge-free InterStim II and allow full-body 1.5 and 3 Tesla MRI-conditional scans.

  • Yesterday, the company announced a recall of its Valiant Navion thoracic stent graft system after a reported patient death in a clinical trial.

  • New SureScan MRI lead scanning parameters 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. The competitor's MRI labeling does not specify parameters for 1.5T scans with B1+rms technology.

  • The new Medtronic scanning parameters increase 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.

  • Decreases wait time from 60 minutes to 5 minutes for maximum duration scans (30 minutes).

  • Price Action: MDT shares increased 0.5% at $118.6 in premarket trading on last check Thursday.

See more from Benzinga

© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.