Medtronic’s Neurostimulators Snag Expanded EU Indication

Friday, April 24, 2015

Source: FDA News

Medtronic’s Activa portfolio of Deep Brain Stimulation Therapy neurostimulators won expanded CE Mark approval for full-body MRI scans, the Ireland-based devicemaker announced Wednesday. The device was previously CE Mark-indicated for MRI scans of the head only, under limited conditions.

The systems enable a patient to continue receiving DBS therapy during MRI scans. Previously, patients had to have their devices switched off before a scan could occur, the company says.

DBS therapy uses an implanted medical device to administer mild electrical pulses to targeted areas of the brain. It is used to treat essential tremor, advanced Parkinson’s disease and chronic intractable primary dystonia. 

The systems are approved for head scans only in the U.S. 

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