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| Prior to performing an MRI on the patients with the Activa DBS neurostimulator, doctors are supposed to inspect X-ray images of the device, such as this one.--Courtesy of Medtronic |
European patients using certain models of Medtronic's Activa line of Deep Brain Stimulation Therapy neurostimulators can receive a full-body MRI scan while continuing to receive therapy, the company announced.
European approval of the MR Conditional label means that authorities on the continent have given Activa patients their blessing to keep the device on during an MRI (provided it is programmed to the appropriate settings), whereas before the sufferers of neurological conditions like Parkinson's disease were supposed to turn the device off.
Medtronic ($MDT) is the first company to receive the label for a DBS device, ahead of competitors like Boston Scientific ($BSX), seller of the Vercise DBS system (albeit not in the U.S.).
"Most patients who we consider for a DBS implant have other conditions which may require MRI," Ludvic Zrinzo, neurosurgeon at London's National Hospital for Neurology and Neurosurgery in London. "The MR Conditional Activa systems mean patients can receive DBS care, and still may have the option of MRI when needed to manage other conditions."
The device was previously approved for use during MRI head scans only. In the U.S., Activa has approval to be used during head scans, but not full-body scans, the company says.
Medtronic says that in order to receive the expanded indication of use, it developed proprietary test and measurement systems, and tested the device in millions of simulated scans using over 38,000 implant conditions.
The company warns that using the Activa during MRI is permitted only under certain conditions. For example, the device's MRI guidelines state that only 1.5-tesla horizontal closed bore MRIs should be used in conjunction with the DBS. Three of the 6 Activa models can be kept on during an MRI, the guidelines say.
In addition to Parkinson's disease, the Activa is approved for use to treat chronic intractable primary dystonia, refractory epilepsy (though not in the U.S.) and treatment-resistant obsessive-compulsive disorder.
Medtronic also sells the Revo MRI SureScan pacemaker, which is it first device in its class to be FDA-approved for use with the imaging modality.
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