Document Detail


The Penumbra System: a mechanical device for the treatment of acute stroke due to thromboembolism.
MedLine Citation:
PMID:  18499798     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND AND PURPOSE: Data from recent reports have indicated that mechanical thrombectomy may have potential as a treatment for acute ischemic stroke. The purpose of this study was to assess the safety and performance of the Penumbra System (PS): a novel mechanical device designed to reduce clot burden in acute stroke due to large-vessel occlusive disease. MATERIALS AND METHODS: A prospective, single arm, independently monitored and core laboratory adjudicated trial enrolled subjects with an acute neurologic deficit consistent with acute stroke, presenting within 8 hours of symptom onset and an angiographically verified occlusion (Thrombolysis in Myocardial Infarction [TIMI] grade 0 or 1) of a treatable intracranial vessel. The primary end point was revascularization of the target vessel to TIMI grade 2 or 3. Secondary end points were the proportion of subjects who achieved a modified Rankin Scale (mRS) score of 2 or less or a 4-point improvement on the National Institutes of Health Stroke Scale (NIHSS) score at 30-day follow-up, as well as all-cause mortality. RESULTS: Twenty-three subjects were enrolled, and 21 target vessels were treated in 20 subjects by the PS. At baseline, mean age was 60 years, mean mRS score was 4.6, and mean NIHSS score was 21. Postprocedure, all 21 of the treated vessels (100%) were successfully revascularized by the PS to TIMI 2 or 3. At 30-day follow-up, 9 subjects (45%) had a 4-point or more NIHSS improvement or an mRS of 2 or less. The all-cause mortality rate was 45% (9 of 20), which is lower than expected in this severe stroke cohort, where 70% of the subjects at baseline had either an NIHSS score of more than 20 or a basilar occlusion. CONCLUSION: Thus, early clinical experience suggests that the PS allows revascularization in certain subjects experiencing acute ischemic stroke.
Authors:
A Bose; H Henkes; K Alfke; W Reith; T E Mayer; A Berlis; V Branca; S Po Sit;
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Publication Detail:
Type:  Journal Article; Multicenter Study     Date:  2008-05-22
Journal Detail:
Title:  AJNR. American journal of neuroradiology     Volume:  29     ISSN:  1936-959X     ISO Abbreviation:  AJNR Am J Neuroradiol     Publication Date:  2008 Aug 
Date Detail:
Created Date:  2008-08-14     Completed Date:  2008-10-31     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8003708     Medline TA:  AJNR Am J Neuroradiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1409-13     Citation Subset:  IM    
Affiliation:
Lenox Hill Hospital, New York, NY, USA.
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MeSH Terms
Descriptor/Qualifier:
Acute Disease
Adult
Aged
Aged, 80 and over
Angiography, Digital Subtraction
Cause of Death
Cerebral Angiography
Cerebral Infarction / mortality,  surgery*
Embolectomy / instrumentation*
Equipment Design
Equipment Safety
Female
Humans
Intracranial Embolism / mortality,  surgery*
Intracranial Thrombosis / mortality,  surgery*
Male
Middle Aged
Neurologic Examination
Postoperative Complications / mortality
Prospective Studies
Thrombectomy / instrumentation*
Tomography, X-Ray Computed
Investigator
Investigator/Affiliation:
Hans Henkes / ; Stefan Lowens / ; Olav Jansen / ; Karsten Alfke / ; Wolfgang Reith / ; Klaus Fassbender / ; Iris Grunwald / ; Joearg Osterhage / ; Panagiotis Papanagiotou / ; Erdem Orberk / ; Thomas E Mayer / ; Stephanie Muller-Schunk / ; Martin Wiesmann / ; Hartmut Bruckmann / ; Klaus Seelos / ; Gunther Fesl / ; Markus Holtmannspotter / ; Markus Dichgans / ; Yvonne Mewald / ; Ansgar Berlis / ; Martin Schumacher / ; Wolf-Dirk Niesen / ; Andreas Hetzel / ; Vincenzo Branca /

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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