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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.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\u003ECurrently, the only approved treatments for thromboembolus in acute stroke are the thrombolytic agents such as tPA. However, clot-removing drugs have a high risk of bleeding complications, and they are not as effective in patients with severe strokes. The Penumbra System is a novel mechanical device designed to remove stroke-associated occlusions from the large brain vessels and is approved for use in acute stroke. The system comprises an aspirating reperfusion catheter, a separator for clearing, and a thrombus removal ring that is designed to capture calcified, hard clots.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Ecerebrovascular disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Einterventional techniques \u0026amp; devices clinical trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003ECurrently, the only approved treatments for thromboembolus in acute stroke are the thrombolytic agents such as tPA. However, clot-removing drugs have a high risk of bleeding complications, and they are not as effective in patients with severe strokes. The Penumbra System is a novel mechanical device designed to remove stroke-associated occlusions from the large brain vessels and is approved for use in acute stroke. The system comprises an aspirating reperfusion catheter, a separator for clearing, and a thrombus removal ring that is designed to capture calcified, hard clots (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E).\u003C\/p\u003E\n         \u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/8\/1\/13.2\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Aspiration System.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-421703721\u0022 data-figure-caption=\u0022Aspiration System.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/8\/1\/13.2\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/8\/1\/13.2\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/8\/1\/13.2\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/10970\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n               \u003Cp id=\u0022p-3\u0022 class=\u0022first-child\u0022\u003EAspiration System.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-4\u0022\u003ECameron McDougall, MD, Barrow Neurological Institute, Phoenix, AZ, reported results from an international multi-center study that was conducted in 125 stroke patients with occluded vessels. The objective of the trial was to assess the safety and the revascularization effectiveness of this novel clot removal system. Patient inclusion criteria included NIH Stroke Scale (NIHSS) score \u223c8, presentation within 8 hours of symptom onset, and a Thrombolysis in Myocardial Infarction (TIMI) score of 0 or I. The primary endpoints were TIMI score II or III and device-related serious adverse events (SAE). Secondary endpoints included \u22654 point improvement on the NIHSS at discharge or modified Rankin Scale (mRS) \u22642 at 30 days, all cause mortality, and incidence of intracranial hemorrhage (ICH).\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EThe median time from symptom onset to procedural start was 4.1 hours; the median time required for revascularization was 45 minutes. Using the Penumbra System, 82% of the treated vessels were revascularized to TIMI II or III, with 41.6% of the patients having a favorable outcome at 30 days. None of the SAEs (3%; 2 perforations; 2 ICHs) was device-related. A total of 35 patients (28%) were found to have ICH at 24 hours, of which 14 (11.2%) were symptomatic (CT evidence of a bleed and a 4-point drop on the NIHSS) and 21 (16.8%) were asymptomatic. At the time of discharge, 58% of the patients had a \u22654 point improvement in NIHSS, and 27% had a \u226510 point improvement in NIHSS or NIHSS 0\u20131. All cause mortality was 26.4%, and 32.8%, respectively, at 30 and 90 days; 25% of patients had a 90-day mRS of \u22642. Due to the effectiveness of the initial aspiration, direct thrombus extraction was used in only 30 of 125 patients.\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EThe Penumbra System was associated with a low rate of serious procedural complications and had an acceptable rate of ICH and all cause mortality. The trend for a better outcome when vessels were opened was consistently observed across all neurological and functional measures.\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EThe US Food and Drug Administration granted clearance of the Penumbra System for revascularization of intracranial vessels in patients with acute ischemic stroke in December 2007. The retrieval ring was used in a minority of patients, and as a result, it was not felt to have been adequately evaluated and therefore was not approved. No complications or adverse events occurred as result of the use of the retrieval ring.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2008 MD Conference Express\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\/8\/1\/13.2.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_figures.js?nzmh81\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzmh81\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}