FDA approves Medtronic’s full-body MR conditional DBS systems

9 December 2015 (Last Updated December 9th, 2015 18:30)

Irish company Medtronic has received US Food and Drug Administration (FDA) approval for its Activa portfolio of deep brain stimulation (DBS) neurostimulators for full-body magnetic resonance imaging (MRI).

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Irish company Medtronic has received US Food and Drug Administration (FDA) approval for its Activa portfolio of deep brain stimulation (DBS) neurostimulators for full-body magnetic resonance imaging (MRI).

The company's MR conditional DBS systems are said to be the only approved full-body MRI scans.

The approval expands access to MRIs, making it safe for patients receiving Medtronic DBS therapy to also receive this important diagnostic standard of care.

The company noted that Activa DBS systems were tested and evaluated across ten million simulated patient scans, spanning more than 38,000 implant conditions.

Conditional on updated MRI guidelines, the approval applies to individuals receiving new Medtronic DBS systems, and to an estimated 43,000 people in the US already receiving Medtronic DBS Therapy.

"Access to full-body MRI scans has been a critical unmet need with DBS therapy."

In the US, around 33.8 million MRI scans were performed in 2013, and about seven out of ten DBS-eligible patients with movement disorders may need an MRI within ten years of receiving their device.

National Parkinson Foundation national medical director Michael Okun said: "Access to full-body MRI scans has been a critical unmet need with DBS therapy, as many patients require MRI imaging but could not always safely obtain it.

"There will be important guidelines for centres to follow in order to apply MRI imaging in patients. However, the availability of this type of imaging is an important step that will facilitate a more optimal care experience."

MRIs use magnetic fields and radio waves to create detailed pictures of organs and tissues, which allow physicians to detect and / or monitor a wide range of health conditions.

These scans can detect stroke, dementia, movement disorders, brain tumours, seizures, diseases of the spine, cancer, musculoskeletal issues and cardiac issues.

The DBS therapy uses a surgically implanted medical device, similar to a pacemaker, to deliver mild electrical pulses to targeted areas of the brain.

The company noted that the stimulation can be programmed and adjusted non-invasively by a trained clinician to increase symptom control and reduce side effects.

The therapy is currently approved in many locations worldwide to treat disabling symptoms of essential tremor, Parkinson's disease, and chronic intractable primary dystonia. US approval for the latter is under a humanitarian device exemption (HDE).

The therapy is also approved to treat refractory epilepsy in Europe, Canada and Australia.


Image: Medtronic world headquarters in Fridley, Minnesota, US. Photo: courtesy of Bobak Ha'Eri.