FDA approves Activa Deep Brain Stimulation neurostimulators for full-body MRI scans- Medtronic

Medtronic has announced that systems within its Activa portfolio of Deep Brain Stimulation (DBS) neurostimulators have received FDA approval for full-body Magnetic Resonance Imaging (MRI) under specific conditions of use. Medtronic's MR Conditional DBS systems are the only approved for full-body MRI scans.

The DBS therapy is currently approved in many locations around the world, including the United States and Europe, for the treatment of the disabling symptoms of essential tremor, Parkinson's disease and chronic intractable primary dystonia, the latter for which approval in the United States is under a Humanitarian Device Exemption (HDE). In Europe, Canada and Australia, DBS therapy is approved for the treatment of refractory epilepsy. DBS therapy is also approved for the treatment of severe, treatment-resistant obsessive-compulsive disorder in the European Union and Australia, and in the United States under an HDE.