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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EA new-generation device used in the treatment of transcatheter closure of congenital heart defects provides easier delivery, better septal apposition, and faster endothelialization than an older version of the device. Early clinical experience showed the device to be efficient and successful in closing both atrial septal defects and patent foramen ovales.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Einterventional techniques \u0026amp; devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecardiology genomics\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecardiology clinical trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EA new-generation device used in the treatment of transcatheter closure of congenital heart defects provides easier delivery, better septal apposition, and faster endothelialization than an older version of the device. Early clinical experience showed the device to be efficient and successful in closing both atrial septal defects (ASDs) and patent foramen ovales (PFOs).\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EJoseph Paolillo, MD, Sanger Heart and Vascular Institute, Levine Children\u0027s Hospital, Charlotte, North Carolina, USA, presented information on the GORE Septal Occluder device, early clinical trial data, and experience with using the device for closure of ASDs and PFOs.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003ESimilar to its earlier version\u2014the GORE HELEX Septal Occluder\u2014the design of the GORE Septal Occluder maintains a number of advantages. Both devices are soft and conformable, have a flattened profile, are easily repositioned, and include a retrieval cord concept.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EAdditional advantages of the new design include an improved delivery system for ease of use and a 5-wire design that provides enhanced disc conformability for rapid closure.\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EEarly clinical data from a number of international trials show a high level of technical success and a high percentage of occlusion rates with the use of the device for closure of both PFO and ASD [Grohmann J et al. \u003Cem\u003ECatheter Cardiovasc Interv\u003C\/em\u003E 2014; Smith B et al. \u003Cem\u003ECatheter Cardiovasc Interv\u003C\/em\u003E 2014; Nyboe C et al. \u003Cem\u003ECatheter Cardiovasc Interv\u003C\/em\u003E 2013].\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EDr. Paolillo provided further early evidence of the highly technical success and closure rates with the new device from his experience at the Levine Children\u0027s Hospital. Since the first implant in January 2013, 22 devices have been implanted: 19 in an ASD trial and 3 in a PFO trial. Current outcomes show technical success with all 3 devices in the PFO trial with immediate complete closure and technical success in 95% (19 of 20 attempts) of the ASD trial with 100% closure by 1 month. He noted that the ASD trial included patients with multifenestrated defects and those with deficient retroaortic tissue.\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EFurther evidence is expected from the GORE Septal Occluder European Union Clinical Evaluation: A Study to Evaluate Clinical Success and Performance in the Treatment of Transcatheter Closure of PFO [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01605851\u0026amp;atom=%2Fspmdc%2F14%2F13%2F18.atom\u0022\u003ENCT01605851\u003C\/a\u003E], a clinical trial that began in 2012.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/13\/18.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzoz81\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}