Advanced

AJNR - American Journal of Neuroradiology

Published ahead of print on May 22, 2008
doi: 10.3174/ajnr.A1110

This Article Figures Only Full Text Full Text (PDF) All Versions of this Article: ajnr.A1110v1 29/7/1409    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Bose, A. Search for Related Content PubMed PubMed Citation Articles by Bose, A.

American Journal of Neuroradiology 29:1409-1413, August 2008
© 2008 American Society of Neuroradiology

INTERVENTIONAL

The Penumbra System: A Mechanical Device for the Treatment of Acute Stroke due to Thromboembolism

A. Bose^a,h, H. Henkes^b, K. Alfke^c, W. Reith^d, T.E. Mayer^e, A. Berlis^f, V. Branca^g, S. Po Sit^h for the Penumbra Phase 1 Stroke Trial Investigators

^a Lenox Hill Hospital, New York, NY
^b Robert Janker Klinik, Bonn, Germany
^c University of Kiel Medical Center, Kiel, Germany
^d Universitätsklinikum des Saarlandes, Homburg/Saar, Germany
^e Universität München Klinikum, Munich, Germany
^f Universität Hospital, Freiburg, Germany
^g Ospedale Maggiore Milano, Milan, Italy
^h Penumbra Inc, San Leandro, Calif

Please address correspondence to Siu Po Sit, Penumbra, Inc, 1351 Harbor Bay Pkwy, Alameda, CA 94502; e-mail: ssit{at}penumbrainc.com

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.

This article has been cited by other articles:

				J. L. Saver, G. W. Albers, B. Dunn, K. C. Johnston, M. Fisher, and for the STAIR VI Consortium Stroke Therapy Academic Industry Roundtable (STAIR) Recommendations for Extended Window Acute Stroke Therapy Trials Stroke, July 1, 2009; 40(7): 2594 - 2600. [Abstract] [Full Text] [PDF]

				I. Q. Grunwald, A. Bose, T. Struffert, B. F. Romeike, M. Politi, W. Reith, and A. Haass Liposuction in Mind Arch Neurol, June 1, 2009; 66(6): 800 - 801. [Full Text] [PDF]

				R.G. Nogueira, A.J. Yoo, F.S. Buonanno, and J.A. Hirsch Endovascular Approaches to Acute Stroke, Part 2: A Comprehensive Review of Studies and Trials AJNR Am. J. Neuroradiol., May 1, 2009; 30(5): 859 - 875. [Abstract] [Full Text] [PDF]

				A. K. Wakhloo, M. J. Deleo III, and M. M. Brown Advances in Interventional Neuroradiology Stroke, May 1, 2009; 40(5): e305 - e312. [Abstract] [Full Text] [PDF]

				H. Hallevi, A. D. Barreto, D. S. Liebeskind, M. M. Morales, S. B. Martin-Schild, A. T. Abraham, J. Gadia, J. L. Saver, the UCLA Intra-Arterial Therapy Investigators, J. C. Grotta, et al. Identifying Patients at High Risk for Poor Outcome After Intra-Arterial Therapy for Acute Ischemic Stroke Stroke, May 1, 2009; 40(5): 1780 - 1785. [Abstract] [Full Text] [PDF]

				R.G. Nogueira, L.H. Schwamm, and J.A. Hirsch Endovascular Approaches to Acute Stroke, Part 1: Drugs, Devices, and Data AJNR Am. J. Neuroradiol., April 1, 2009; 30(4): 649 - 661. [Abstract] [Full Text] [PDF]

				H.J. Cloft, A. Rabinstein, G. Lanzino, and D.F. Kallmes Intra-Arterial Stroke Therapy: An Assessment of Demand and Available Work Force AJNR Am. J. Neuroradiol., March 1, 2009; 30(3): 453 - 458. [Abstract] [Full Text] [PDF]