EU approval for Medtronic DBS systems improves access to full-body MRI scans


sponsored by Medtronic plc

Author: SponsoredPublished: 28 April 2015

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MRI scan

People with Parkinson’s receiving deep brain stimulation (DBS) therapy finally have the option of full-body MRI scans – without having to switch off their device

Deep brain stimulation patients will for the first time have access to full-body MRI scans – with no interruption to their treatment – thanks to DBS systems approved this month (April) by European regulators.

DBS therapy, an increasingly common treatment for neurological movement conditions like Parkinson’s, uses a surgically implanted medical device, similar to a pacemaker, to deliver mild electrical pulses to specific areas of the brain.

It’s estimated that seven out of 10 patients eligible for DBS therapy may need an MRI following their implant.1 But until now, such patients have had to turn their DBS systems off for scans – or forego MRI altogether due to the potential health risks and complications of using the two technologies together.

The extended approval applies to systems in Medtronic’s Activa® portfolio of DBS therapy products – making these the first and only systems classified as ‘MRI full-body safe’ in Europe.

The development means an estimated 13,000 existing Medtronic DBS patients in Europe – as well as those receiving a new system – will now have improved access to MRI technology.2

Dr John Thornton, medical physicist at the National Hospital for Neurology and Neurosurgery in London, said: “MRI is commonly the method of choice when diagnosing disease or monitoring existing conditions, but its use has often been limited in patients receiving DBS therapy. Patients receiving DBS therapy can now receive more advantages of MRI.”

Ludvic Zrinzo, neurosurgeon at the National Hospital for Neurology and Neurosurgery, added: “Most patients we consider for a DBS implant have other conditions which may require MRI. The ‘MR Conditional’ Activa® systems mean patients can receive DBS care, and may still have the option of MRI when needed to manage other conditions.”

To obtain approval for its ‘MR Conditional’ DBS systems, Medtronic developed proprietary test and measurement systems, together with advanced electromagnetic modelling tools. Existing Activa® DBS systems were rigorously tested and evaluated across millions of simulated patient scans spanning over 38,000 unique implant conditions to demonstrate patient safety.

Lothar Krinke PhD, vice president and general manager of the Brain Modulation business at Medtronic, said: “We are proud to be the only company to offer DBS systems to patients across Europe allowing them access to full-body MRI technology. Continuous advancements such as these set Medtronic apart and reinforce our commitment to the field of brain modulation.”

Knut-Johan Onarheim, president of the European Parkinson’s Disease Association (Parkinson’s Europe), commented:  “The recent European regulatory approval of Medtonic’s DBS systems represents a great advancement in patient care. It means many more people receiving DBS therapy can benefit from the advantages of MRI technology.”

This article was sponsored by Medtronic plc. The information in this article is given for information purposes only and does not represent an endorsement by Parkinson’s Europe of any particular treatments, products or companies. This article is not a substitute for advice from your doctor, pharmacist or other healthcare professional. Parkinson’s Life makes no representations or warranties of any kind, express or implied, about the completeness or accuracy of information provided.

1. Based on recommendations by European and national medical societies.

2. Under specific conditions of use. Before conducting an MRI examination on a patient with any implanted Medtronic DBS device, please refer to the MRI guidelines for Medtronic deep brain stimulation systems located in English at Examination guidelines for other European countries will be available from June onwards.

The following video was supplied by Medtronic:

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