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MR-Conditional Pacemaker System Approved in Japan

By MedImaging International staff writers
Posted on 31 Oct 2012
Image: The Advisa DR MRI SureScan pacing system (Photo courtesy of Medtronic).
Image: The Advisa DR MRI SureScan pacing system (Photo courtesy of Medtronic).
With the use of new magnetic resonance imaging (MRI)-conditional pacing technology, pacemaker patients will have access to full body scanners, without positioning restriction in the MRI scanner.

MRI is the standard of care in soft tissue imaging, providing data not seen with X-ray, computed tomography (CT) or ultrasound scan, and critical for early detection, diagnosis, and treatment. Medtronic, Inc. (Minneapolis, MN, USA), announced the Japanese regulatory approval and launch of the Advisa DR MRI SureScan pacing system. The Advisa MRI system is the first and only MR-conditional pacemaker available to patients in Japan, the world’s second largest market for medical devices.

Advisa MRI was exclusively assessed and approved for use as labeled with MRI scanners in Japan. The system includes an Advisa MRI device and two CapSureFix MRI SureScan leads, which must be used in tandem. “Until recently there was a significant unmet need for patients with pacemakers to have access to MRI technology,” said Ken Okumura MD, professor and chief, department of cardiology, Graduate School of Medicine, Hirosaki University (Aomori, Japan) and president of the Japanese Heart Rhythm Society. “Now physicians and patients have a choice of pacing systems that allow access to the invaluable benefits of MRI technology.”

The first SureScan pacemaker system was introduced in Europe in 2008 and its use in the MRI environment is supported by extensive computer modeling and clinical studies, as well as real-life data. Up to now, Medtronic has sold almost 100,000 SureScan devices worldwide, and thousands of SureScan patients have been able to safely undergo an MRI that would have been denied to them with a conventional pacemaker.

About 400,000 people in Japan have implanted pacemakers. However, until the availability of Medtronic's SureScan pacing systems, patients with pacemakers have been contraindicated in Japan from receiving MRI scans. There is the possibility for pacemakers to interact with MRI units in a way that could undesirably affect the device function or patient safety. According to estimates, 50%-75% of patients worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices.

The Advisa DR MRI SureScan pacing system is not yet available in the United States. The Revo MRI SureScan pacing system was US Food and Drug Administration (FDA) approved in February 2011.

The MRI pacing system provides patients with dedicated technology, including the MVP (managed ventricular pacing) algorithm, which is shown to reduce unnecessary ventricular pacing by 99%. Additional features include (1) complete automaticity with ventricular and atrial capture management (VCM and ACM) and antitachycardia pacing (ATP). (2) Diagnostic tools such as the Cardiac Compass Report and tachyarrhythmia management tools that assist in the early detection of atrial fibrillation (AF). (3) Remote follow-up via Medtronic’s CareLink Network, which transmits detailed arrhythmia and diagnostic device data to a doctor’s clinic. (4) Lastly, a rate drop response that identifies abrupt cardiac slowing and responds by pacing the heart at an elevated rate, which may decrease the frequency of syncopal episodes in patients with apparent cardio-inhibitory vasovagal syncope.

In collaboration with leading researchers, clinicians, and scientists worldwide, Medtronic provides a wide range of medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.

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89 (32.901763916016): SELECT id,name,title FROM jos_deeppockets WHERE cat=10 AND TYPE='file_folder' AND published=1 AND id != 294743300 AND id != 294743301 AND id != 294743302 AND id != 294743303 AND id != 294743304 AND id != 294743305 AND id != 294743306 AND id != 294743307 AND id != 294743308 AND id != 294743309 AND id != 294743310 AND metakey != 'aacc' ORDER BY `ordering`
90 (50.067901611328): SELECT show_live FROM jos_com_show_setting LIMIT 1
91 (30.040740966797): SELECT show_live FROM jos_com_show_setting LIMIT 1
92 (27.894973754883): SELECT show_live FROM jos_com_show_setting LIMIT 1
93 (27.894973754883): SELECT show_live FROM jos_com_show_setting LIMIT 1
94 (33.855438232422): SELECT show_live FROM jos_com_show_setting LIMIT 1
95 (29.087066650391): SELECT show_live FROM jos_com_show_setting LIMIT 1
96 (28.133392333984): SELECT show_live FROM jos_com_show_setting LIMIT 1
97 (28.133392333984): SELECT show_live FROM jos_com_show_setting LIMIT 1
98 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1
99 (27.894973754883): SELECT show_live FROM jos_com_show_setting LIMIT 1
100 (27.894973754883): 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 (27.894973754883): SELECT show_live FROM jos_com_show_setting LIMIT 1
104 (91.791152954102): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
105 (46.968460083008): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
106 (51.021575927734): 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=294743191 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
107 (46.014785766602): 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=294743191 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
108 (79.154968261719): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
109 (61.03515625): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
110 (47.922134399414): 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=294743191 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
111 (526.18980407715): 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=294743191 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
112 (!!!!! 1044.9886322021): 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 (508.06999206543): 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 (77.009201049805): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
115 (46.014785766602): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
116 (56.028366088867): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
117 (39.100646972656): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
118 (53.167343139648): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
119 (39.100646972656): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
120 (41.961669921875): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
121 (35.04753112793): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
122 (289.9169921875): SELECT * FROM trending_articles WHERE `journal_id` = 10 AND `timestamp` <= NOW() + INTERVAL 7 DAY ORDER BY `order`
123 (!!!!! 18919.229507446): 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 (488.0428314209): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294743191 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294743191 AND type='deeppockets_item' AND published='1' LIMIT 1
125 (!!!!! 7261.9915008545): ( 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 (74.148178100586): ( 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 (29.802322387695): 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 (36.954879760742): 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 (29.087066650391): 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 (262.97569274902): 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 (64.13459777832): 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 (30.040740966797): 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 (30.040740966797): 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 (461.81678771973): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
136 (356.91261291504): SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
137 (195.02639770508): SELECT name FROM jos_deeppockets WHERE id=212
138 (32.186508178711): SELECT name FROM jos_deeppockets WHERE id=212
139 (522.85194396973): 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((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
140 (433.92181396484): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))212((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
141 (74.863433837891): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
142 (49.114227294922): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
143 (!!!!! 8441.2097930908): TRUNCATE TABLE jos_trademed_module
144 (90.122222900391): 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=294743191 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
145 (55.074691772461): 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=294743191 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
146 (769.85359191895): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
147 (48.87580871582): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
148 (51.975250244141): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
149 (41.007995605469): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
150 (!!!!! 1051.9027709961): 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 (54.836273193359): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
152 (77.009201049805): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
153 (37.908554077148): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294743191 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294743191 AND type='deeppockets_item' AND published='1' LIMIT 1
154 (30.040740966797): 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 (26.941299438477): 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 (35.04753112793): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1
157 (107.0499420166): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
158 (83.92333984375): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294743191 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294743191 AND published='1' LIMIT 1
159 (39.100646972656): select jos_twitters.link from jos_twitters where cat=10
160 (30.994415283203): 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 (31.948089599609): select jos_linkedin.link from jos_linkedin where cat=10
163 (289.9169921875): update jos_bannersmanager_banner set impmade=impmade+1 where id in(14615,14202,14203)
164 (!!!!! 1035.9287261963): insert into jos_banners_delta values (14615,'2025-06-26 04:15:53','216.73.216.249','view'),(14202,'2025-06-26 04:15:53','216.73.216.249','view'),(14203,'2025-06-26 04:15:53','216.73.216.249','view')