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MRI Pacing System Recommended for U.S. Regulatory Approval

By MedImaging International staff writers
Posted on 15 Apr 2010
A new magnetic resonance imaging (MRI) pacing system was designed to address safety concerns around MRI procedures for patients who have implanted pacemakers. The device includes hardware modifications to the device and leads that are designed to reduce or eliminate several hazards produced by the MRI environment.

The U.S. Food and Drug Administration (FDA; Silver Spring, MD, USA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted unanimously in favor of approval with conditions of the Revo MRI SureScan pacing system designed as MR Conditional, or safe for use in magnetic resonance imaging (MRI) systems under specified conditions.

MRI procedures are not recommended in the United States for patients who currently have implanted pacemakers; if approved, Revo MRI has the potential to be the first FDA-approved pacing system designed for use in the MRI setting.

The FDA's Circulatory System Devices Panel, which met March 22, 2010, recommended Revo MRI for approval with conditions related to the planned postmarket study, health care professional training, and labeling to reflect MRI scans are to be conducted with the full Revo MRI SureScan pacing system. The FDA will consider the panel's recommendation in its review of Revo MRI; however, it is not bound by its Advisory Committee's recommendations. The pacing system was developed by Medtronic, Inc. (Fridley, MN, USA).

"MRI is critical in the diagnosis of many serious conditions; however, patients with current pacemakers most often do not have access to this vital technology," said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. "The result of [this] panel brings Medtronic one step closer to helping address an important unmet patient need. We look forward to working with the FDA during the regulatory process so that we may provide certain pacemaker patients with access to MRI scans.”

The number of MRI scans performed increases each year, as does the number of people with implanted cardiac devices. It is estimated that more than 200,000 patients yearly in the United States have to forego an MRI scan because they have a pacemaker due to the risks involved, including interference with pacemaker operation, damage to system components, lead or pacemaker dislodgement, heating of the lead tips and unintended cardiac stimulation. MRI scans allow physicians to make a wide range of health diagnoses by viewing highly detailed images of internal organs, blood vessels, muscle, joints, tumors, and areas of infection.

The FDA panel reviewed safety and effectiveness data from a prospective, randomized multi-center trial at 42 centers around the world featuring 464 implanted patients. Major inclusion criteria included standard Class I or II dual chamber pacemaker indication, which allowed for pacemaker-dependent patients. Patients were excluded if they had previously implanted medical devices or abandoned leads. Patients were randomized at implant either to receive an MRI or not to receive an MRI.

The primary endpoints evaluated were safety and effectiveness of the Revo MRI pacing system in the MRI environment. For safety, the MRI group was evaluated for MRI procedure-related complications through one-month post-MRI. The primary effectiveness endpoint tested equivalence between MRI versus control for atrial and ventricular pacing capture thresholds and atrial and ventricular sensed amplitudes through one-month post-MRI.

Since MRI scanners may cause traditional pacemakers to misinterpret MRI-generated electrical noise and withhold pacing therapy or deliver unnecessary pacing therapy, this new pacemaker includes a new SureScan feature that sets the device into an appropriate mode for the MRI environment.

The device and leads also contain radiopaque markers, viewable via X-ray, to indicate that the device is MR-conditional. MR-conditional is a term used to indicate that a device may be used in the MRI environment under certain conditions, such as a particular type of MRI scanner and scanner settings.

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89 (35.04753112793): 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 (!!!!! 3192.9016113281): SELECT show_live FROM jos_com_show_setting LIMIT 1
91 (87.976455688477): SELECT show_live FROM jos_com_show_setting LIMIT 1
92 (31.948089599609): SELECT show_live FROM jos_com_show_setting LIMIT 1
93 (28.848648071289): SELECT show_live FROM jos_com_show_setting LIMIT 1
94 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1
95 (28.133392333984): SELECT show_live FROM jos_com_show_setting LIMIT 1
96 (27.894973754883): SELECT show_live FROM jos_com_show_setting LIMIT 1
97 (27.894973754883): SELECT show_live FROM jos_com_show_setting LIMIT 1
98 (28.133392333984): SELECT show_live FROM jos_com_show_setting LIMIT 1
99 (28.133392333984): SELECT show_live FROM jos_com_show_setting LIMIT 1
100 (32.901763916016): SELECT show_live FROM jos_com_show_setting LIMIT 1
101 (38.14697265625): SELECT show_live FROM jos_com_show_setting LIMIT 1
102 (30.040740966797): SELECT show_live FROM jos_com_show_setting LIMIT 1
103 (29.087066650391): SELECT show_live FROM jos_com_show_setting LIMIT 1
104 (82.969665527344): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
105 (46.968460083008): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
106 (53.882598876953): 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=294728948 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
107 (509.97734069824): 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=294728948 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=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
109 (46.014785766602): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
110 (62.942504882812): 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=294728948 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
111 (746.9654083252): 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=294728948 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
112 (!!!!! 4708.0516815186): 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 (351.90582275391): 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 (80.82389831543): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
115 (44.822692871094): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
116 (51.975250244141): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
117 (41.007995605469): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
118 (46.014785766602): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
119 (36.954879760742): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
120 (45.061111450195): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
121 (40.054321289062): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
122 (180.00602722168): SELECT * FROM trending_articles WHERE `journal_id` = 10 AND `timestamp` <= NOW() + INTERVAL 7 DAY ORDER BY `order`
123 (!!!!! 36085.12878418): 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 (!!!!! 4779.1004180908): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294728948 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294728948 AND type='deeppockets_item' AND published='1' LIMIT 1
125 (!!!!! 11231.184005737): ( 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 (!!!!! 4328.0124664307): ( 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 (46.968460083008): 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 (32.901763916016): 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 (38.14697265625): 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 (30.994415283203): 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 (242.94853210449): 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 (37.193298339844): 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 (34.809112548828): 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 (391.00646972656): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
136 (258.9225769043): SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
137 (43.869018554688): SELECT name FROM jos_deeppockets WHERE id=212
138 (37.908554077148): SELECT name FROM jos_deeppockets WHERE id=212
139 (558.13789367676): 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((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
140 (499.01008605957): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))212((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
141 (74.863433837891): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
142 (46.014785766602): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
143 (!!!!! 13207.912445068): TRUNCATE TABLE jos_trademed_module
144 (102.04315185547): 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=294728948 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
145 (87.02278137207): 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=294728948 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
146 (!!!!! 3329.9922943115): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
147 (86.069107055664): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
148 (65.088272094727): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
149 (43.869018554688): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
150 (!!!!! 1143.9323425293): 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 (56.982040405273): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
152 (45.061111450195): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
153 (36.954879760742): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294728948 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294728948 AND type='deeppockets_item' AND published='1' LIMIT 1
154 (30.994415283203): 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 (29.087066650391): 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 (30.994415283203): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1
157 (64.13459777832): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
158 (43.869018554688): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728948 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728948 AND published='1' LIMIT 1
159 (46.014785766602): select jos_twitters.link from jos_twitters where cat=10
160 (29.087066650391): select jos_facebook.link from jos_facebook where cat=10
161 (28.848648071289): select jos_google_plus.link from jos_google_plus where cat=10
162 (28.133392333984): select jos_linkedin.link from jos_linkedin where cat=10
163 (290.1554107666): update jos_bannersmanager_banner set impmade=impmade+1 where id in(14615,14202,14203)
164 (!!!!! 1401.9012451172): insert into jos_banners_delta values (14615,'2025-06-28 11:28:57','216.73.216.249','view'),(14202,'2025-06-28 11:28:57','216.73.216.249','view'),(14203,'2025-06-28 11:28:57','216.73.216.249','view')