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Radiosurgery Suite Receives US Clearance for Noninvasive Surgical Procedures

By MedImaging International staff writers
Posted on 20 Feb 2013
A new dedicated radiosurgery system has been developed for performing radiosurgery using real-time tumor tracking and motion management technologies.

Varian Medical Systems (Palo Alto, CA, USA) has received US Food and Drug Administration (FDA) 510(k) clearance for the company’s Edge radiosurgery suite. More...
“The Edge suite represents a new paradigm in radiosurgery, offering clinicians a system that combines Varian’s world-class technologies in an end-to-end solution for planning and delivering radiosurgery treatments,” said Chris Toth, vice president of marketing for Varian’s oncology systems business. “It integrates Varian’s state-of-the-art radiosurgery technology with tools for real-time imaging, tracking, and patient positioning. It enables fast, accurate delivery of stereotactic radiosurgery for treating lesions, tumors, and conditions anywhere in the body where radiotherapy is indicated, including tumors of the lung, prostate, spine, and brain.”

Recent FDA 510(k) clearances cover the following technologies that are integrated into the Edge radiosurgery suite. These new technologies are also being made available as upgrades to other compatible Varian systems: The PerfectPitch couch, which is an integrated 6° of freedom (6DoF) treatment couch that provides the precision, accuracy, and flexibility required to position patients optimally, adjust their position to correct for any misalignments, and support them comfortably during treatment. The couch has been designed for the accuracy and functionality required to provide radiosurgery treatments in the brain and in the rest of the body.

The advanced motion and image-guided radiotherapy (IGRT) package is a sophisticated motion management package that offers clinicians many options for using real-time imaging during radiotherapy treatments. It also enables expanded use of fluoroscopy and four-dimensional (4D) cone-beam computed tomography (CT)—imaging techniques that show motion over time—to better compensate for tumor motion during treatment.

The intracranial radiosurgery package is an integrated set of technologies for planning and delivering stereotactic radiosurgery treatments for tumors or functional abnormalities in the brain. The intracranial radiosurgery package supports the accurate delivery of radiation using multiple beam-shaping options, including Varian's high-definition multileaf collimator and radiosurgery conical collimators, and is compatible with both frame-based and frameless patient immobilization approaches.

Lastly, the Calypso system, which has several enhancements, have been incorporated into the Calypso system for real time tracking. The system utilizes transponders, or position signaling devices, that are implanted in or around a tumor, or placed on the surface of the body and monitored to track motion during treatment. New enhancements increase the rate of transponder signal processing in order to track faster types of motion, such as respiratory motion, in real time. The system is also compatible with the couch rotations that are frequently employed to optimize targeting during treatments in the lung. The technology also includes updated usability features designed to streamline treatments and optimize the user experience.

One optional Edge suite subcomponent is still pending FDA 510(k) clearance: Calypso anchored Beacon transponders for implantation in the lung to guide lung radiosurgery procedures.

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88 (88.930130004883): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294744868 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
89 (578.16505432129): SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294744868 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
90 (72.002410888672): 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`
91 (147.81951904297): SELECT show_live FROM jos_com_show_setting LIMIT 1
92 (47.206878662109): SELECT show_live FROM jos_com_show_setting LIMIT 1
93 (42.915344238281): SELECT show_live FROM jos_com_show_setting LIMIT 1
94 (42.915344238281): SELECT show_live FROM jos_com_show_setting LIMIT 1
95 (41.961669921875): SELECT show_live FROM jos_com_show_setting LIMIT 1
96 (58.889389038086): SELECT show_live FROM jos_com_show_setting LIMIT 1
97 (46.968460083008): SELECT show_live FROM jos_com_show_setting LIMIT 1
98 (37.908554077148): SELECT show_live FROM jos_com_show_setting LIMIT 1
99 (36.954879760742): SELECT show_live FROM jos_com_show_setting LIMIT 1
100 (36.954879760742): SELECT show_live FROM jos_com_show_setting LIMIT 1
101 (41.961669921875): SELECT show_live FROM jos_com_show_setting LIMIT 1
102 (38.862228393555): SELECT show_live FROM jos_com_show_setting LIMIT 1
103 (42.200088500977): SELECT show_live FROM jos_com_show_setting LIMIT 1
104 (37.908554077148): SELECT show_live FROM jos_com_show_setting LIMIT 1
105 (!!!!! 1712.0838165283): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
106 (91.791152954102): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
107 (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 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=294744868 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
108 (684.97657775879): 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=294744868 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
109 (!!!!! 5327.9399871826): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
110 (167.8466796875): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
111 (74.148178100586): 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=294744868 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
112 (761.98577880859): 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=294744868 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
113 (870.2278137207): 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 (748.87275695801): 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
115 (138.99803161621): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
116 (93.936920166016): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
117 (87.02278137207): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
118 (63.180923461914): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
119 (79.870223999023): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
120 (59.843063354492): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
121 (73.19450378418): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
122 (61.988830566406): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
123 (489.95018005371): SELECT * FROM trending_articles WHERE `journal_id` = 10 AND `timestamp` <= NOW() + INTERVAL 7 DAY ORDER BY `order`
124 (!!!!! 51875.114440918): 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
125 (524.99771118164): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294744868 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294744868 AND type='deeppockets_item' AND published='1' LIMIT 1
126 (!!!!! 17447.948455811): ( 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 (!!!!! 5548.9540100098): ( 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
128 (55.074691772461): 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 (35.04753112793): 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
130 (72.002410888672): 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 (34.093856811523): 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
132 (378.84712219238): 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 (51.975250244141): 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
134 (37.908554077148): 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 (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
136 (!!!!! 3030.0617218018): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
137 (550.0316619873): SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
138 (!!!!! 2054.9297332764): SELECT name FROM jos_deeppockets WHERE id=211
139 (94.890594482422): SELECT name FROM jos_deeppockets WHERE id=211
140 (900.0301361084): 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 '((;)|(^))211((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
141 (!!!!! 2939.2242431641): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))211((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
142 (126.83868408203): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
143 (46.968460083008): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
144 (!!!!! 20150.184631348): TRUNCATE TABLE jos_trademed_module
145 (!!!!! 6484.9853515625): 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=294744868 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
146 (!!!!! 6125.9269714355): 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=294744868 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
147 (!!!!! 2415.8954620361): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
148 (!!!!! 1198.0533599854): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
149 (!!!!! 2413.9881134033): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
150 (70.095062255859): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
151 (!!!!! 1707.0770263672): 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
152 (!!!!! 1087.1887207031): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
153 (972.98622131348): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
154 (74.863433837891): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294744868 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294744868 AND type='deeppockets_item' AND published='1' LIMIT 1
155 (157.11784362793): 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=211 or channel_id is null)
156 (35.04753112793): 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=211 or channel_id is null)
157 (859.02214050293): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1
158 (!!!!! 2154.8271179199): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
159 (297.06954956055): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294744868 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294744868 AND published='1' LIMIT 1
160 (!!!!! 3925.8003234863): select jos_twitters.link from jos_twitters where cat=10
161 (526.90505981445): select jos_facebook.link from jos_facebook where cat=10
162 (257.01522827148): select jos_google_plus.link from jos_google_plus where cat=10
163 (225.06713867188): select jos_linkedin.link from jos_linkedin where cat=10