First Multi-Center Real World Clinical Data on Use of the Penumbra System in Acute Ischemic Stroke is Presented at the International Stroke Conference’s “Best Science of the ISC” Session

Data Demonstrates A Link Between High Revascularization Rates and Good Clinical Outcomes In A Large Stroke Cohort And Confirms High Standards Of Safety And Effectiveness Set By The Penumbra Pivotal Trial

First Multi-Center Real World Clinical Data on Use of the Penumbra System in Acute Ischemic Stroke is Presented at the International Stroke Conference’s “Best Science of the ISC” Session

Clinical results of a 139 patient, multi-center study organized by 7 major community and academic acute stroke treatment centers in the US and Europe were presented today at the 2009 International Stroke Conference’s “Best Science of the ISC” session by Dr. Robert Tarr, Chief, Neuroradiology, University Hospitals Case Medical Center, Professor of Radiology and Neurological Surgery at Case Western Reserve University School of Medicine, and President of the Society of Neurointerventional Surgery, on behalf of the investigator group.

Penumbra POST is a retrospective, multi-center study that represents the first large, organized review of real world experience with the Penumbra System since its worldwide launch more than a year ago. All patients reviewed had presentation characteristics that were consistent with acute ischemic stroke including NIH Stroke Scale (NIHSS) score ≥ 8, presentation within 8 hours of symptom onset, and a complete or near-complete (TIMI grade 0 or I) occlusion of a large intracranial vessel. At enrollment, the mean patient age was 64 years, the mean NIHSS score was 16, and the median time from symptom onset to start of the procedure was 4.5 hours. The 90 day follow-up data was collected on a forward looking basis.

After use of the Penumbra System 84% of patients were successfully revascularized to a TIMI score of II or III. There were 8/139 (5.8%) procedural SAEs, and 13% were found to have intracranial hemorrhage (ICH) at 24 hours of which 7.2% were symptomatic. All cause mortality is 22%. At discharge, 56% of patients had an NIHSS improvement of at least 4 points, and of the patients who have reached 90 days follow-up, 40% had an mRS ≤ 2, indicating good functional outcome and the ability to live independently.

“It’s encouraging to see the primary outcomes of revascularization and safety in this real world clinical experience mirror the results of the Penumbra Pivotal Trial. The finding of a high revascularization rate with a low symptomatic hemorrhage rate in a large, monitored population of patients treated with the Penumbra System is a reaffirmation of the safe mechanism of action of this device. There has been some discussion in the neuroscience community that not all modes of revascularization lead to good outcomes. This data would seem to bring that argument into question,” said Dr. Tarr.

“The 40% of patients that were living independently at 90 days is an important and compelling finding, especially given the real world use of the device outside of a pre-market clinical trial setting. This result shows that when used according to individual stroke treatment center protocols, the Penumbra System therapy results in a high rate of positive clinical outcomes for patients suffering from large vessel occlusive disease,” said Prof. Dr. Olav Jansen, Director of the Institute for Neuroradiology, University of Kiel, Germany.

The Penumbra System is a package of tools used by neuro interventional specialists to remove clots from the large vessels of the brain that are causing a stroke. It works on the proximal surface of the occlusion, optimizing safety and eliminating the need for navigation beyond the clot. The Penumbra System is comprised of an aspiration platform containing multiple devices that are size-matched to the specific neurovascular anatomy allowing clots to be gently aspirated out of intracranial vessels. It was launched in Europe and the United States between June, 2007 and January, 2008. The Penumbra System is now commercially available worldwide including Asia, North and South America.

ABOUT PENUMBRA

Penumbra, Inc. (www.penumbrainc.com ) is a medical device company committed to delivering clinically beneficial products that help patients suffering from stroke and other neurovascular diseases. Penumbra’s global headquarters is located in Alameda, California with sales operations in the United States, Europe and Asia.

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Penumbra, Inc.
Media Relations:
Elizabeth Zaldivar, 510-748-3200