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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.
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