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Updated FDA Labeling for the Use of Deep Brain Neurostimulators in Full-Body MR Diagnostic Scan

By MedImaging International staff writers
Posted on 15 Dec 2015
The US Food and Drug Administration (FDA; Silver Spring, MD USA) has updated labeling of a series of Deep Brain Stimulation (DBS) neuro-stimulators, produced by a large medical technology company, enabling increased patient access to MRI scans.

The DBS neurostimulators are the first to receive FDA approval for full-body Magnetic Resonance Imaging (MRI) scans, dependent on specific conditions of use, and enable patients receiving DBS therapy to undergo MRI imaging. Previously, patients DBS were limited to low power Radio Frequency (RF) MRI head scans and the DBS system had to be switched off before the scan. The FDA approval enables increased MRI RF power limits, and scanning, and when programmed correctly the DBS systems can even continue to deliver therapy during scans.

The Medtronic (Dublin, Ireland) Activa portfolio of DBS Therapy systems uses a surgically implanted medical device to deliver mild electrical pulses to precisely targeted areas of the brain. A trained clinician can program and adjusted the system noninvasively to maximize symptom control and minimize side effects. Medtronic DBS Therapy is used by more than 130,000 patients worldwide.

Medtronic tested and evaluated the DBS systems using advanced electromagnetic modeling tools across 10 million simulated patient scans, and over 38,000 unique implant conditions, in order to ensure patient safety. The therapy is currently approved in US and Europe, for the treatment of the symptoms of Parkinson's disease, and chronic intractable primary dystonia, and in Europe, Canada and Australia for the treatment of refractory epilepsy. DBS therapy is also approved for the treatment of severe, treatment-resistant Obsessive-Compulsive Disorder (OCD) in Australia, the US (under Humanitarian Device Exemption regulations) and in the European Union.

Michael S. Okun, national medical director, US National Parkinson Foundation, 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 centers 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. The use of MRI as a diagnostic tool has grown significantly, and Medtronic is proud to offer the only DBS systems that allow patients access to full-body MRIs."

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97 (27.894973754883): SELECT show_live FROM jos_com_show_setting LIMIT 1
98 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1
99 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1
100 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1
101 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1
102 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1
103 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1
104 (64.13459777832): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
105 (41.007995605469): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
106 (50.067901611328): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294761801 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
107 (44.107437133789): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294761801 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
108 (98.943710327148): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
109 (45.061111450195): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
110 (44.822692871094): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294761801 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
111 (530.00450134277): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294761801 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
112 (716.20941162109): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
113 (396.9669342041): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
114 (112.05673217773): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
115 (103.95050048828): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
116 (189.06593322754): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
117 (41.961669921875): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
118 (60.081481933594): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
119 (44.107437133789): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
120 (44.107437133789): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
121 (37.193298339844): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
122 (391.96014404297): SELECT * FROM trending_articles WHERE `journal_id` = 10 AND `timestamp` <= NOW() + INTERVAL 7 DAY ORDER BY `order`
123 (!!!!! 19405.126571655): SELECT * FROM jos_deeppockets WHERE jos_deeppockets.cat = 10 AND jos_deeppockets.type = 'deeppockets_item' AND jos_deeppockets.published = 1 AND jos_deeppockets.created + INTERVAL 14 DAY >= NOW() ORDER BY jos_deeppockets.hits DESC LIMIT 7
124 (535.01129150391): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294761801 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294761801 AND type='deeppockets_item' AND published='1' LIMIT 1
125 (!!!!! 7071.9718933105): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
126 (70.095062255859): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
127 (36.954879760742): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1
128 (30.040740966797): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1
129 (64.13459777832): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1
130 (33.855438232422): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1
131 (304.9373626709): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1
132 (36.001205444336): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1
133 (30.994415283203): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1
134 (49.114227294922): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1
135 (553.13110351562): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
136 (355.95893859863): SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
137 (212.9077911377): SELECT name FROM jos_deeppockets WHERE id=212
138 (34.093856811523): SELECT name FROM jos_deeppockets WHERE id=212
139 (590.08598327637): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))212((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
140 (463.96255493164): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))212((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
141 (70.095062255859): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
142 (48.87580871582): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
143 (!!!!! 14207.83996582): TRUNCATE TABLE jos_trademed_module
144 (110.14938354492): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294761801 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
145 (53.167343139648): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294761801 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
146 (867.12837219238): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
147 (60.796737670898): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
148 (87.02278137207): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
149 (45.061111450195): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
150 (!!!!! 1319.1699981689): SELECT jos_item.* FROM jos_item INNER JOIN jos_number ON jos_item.numberID=jos_number.id WHERE 1=1 AND (jos_item.imgMini<>'') AND jos_item.type='L' AND jos_item.numberID= ( SELECT jos_number.id FROM jos_number WHERE jos_number.journalID IN (10) and jos_number.id in (select distinct jos_number.id from jos_number join jos_item on jos_item.numberid=jos_number.id where jos_item.type='P') ORDER BY (CONVERT(SUBSTRING(issue,1,2),SIGNED) + (CONVERT(SUBSTRING(issue,3,2),SIGNED)*100)) DESC LIMIT 0,1 ) ORDER BY RAND() DESC LIMIT 6
151 (60.081481933594): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
152 (40.054321289062): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
153 (35.04753112793): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294761801 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294761801 AND type='deeppockets_item' AND published='1' LIMIT 1
154 (29.802322387695): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=212 or channel_id is null)
155 (31.948089599609): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=212 or channel_id is null)
156 (38.862228393555): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1
157 (71.048736572266): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
158 (46.968460083008): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294761801 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294761801 AND published='1' LIMIT 1
159 (37.908554077148): select jos_twitters.link from jos_twitters where cat=10
160 (32.901763916016): select jos_facebook.link from jos_facebook where cat=10
161 (30.994415283203): select jos_google_plus.link from jos_google_plus where cat=10
162 (32.186508178711): select jos_linkedin.link from jos_linkedin where cat=10
163 (374.07875061035): update jos_bannersmanager_banner set impmade=impmade+1 where id in(14615,14202,14203)
164 (!!!!! 1219.9878692627): insert into jos_banners_delta values (14615,'2025-06-22 10:30:46','216.73.216.120','view'),(14202,'2025-06-22 10:30:46','216.73.216.120','view'),(14203,'2025-06-22 10:30:46','216.73.216.120','view')