Healthcare Industry News:  Penumbra 

Devices Interventional Radiology Neurology

 News Release - October 21, 2009

The Interventional Management of Stroke (IMS) III Trial Protocol Now Includes The Penumbra System, An Aspiration-Based Thrombectomy Device for Interventional Debulking and Removal of Cerebral Clots in Acute Stroke Patients

ALAMEDA, Calif.--(HSMN NewsFeed)--Today, Penumbra, Inc. announced that The Penumbra System(R) has been added as a therapeutic option in the IV/IA arm of the IMS III Trial, a prospective, randomized, controlled, international study of acute stroke intervention sponsored by the University of Cincinnati and the National Institute of Neurological Disorders and Stroke (NINDS).

We welcome the addition of Penumbra as one of the intra-arterial therapies available to our investigators in the IMS III trial. The trial is examining if a combined approach of intravenous r-tPA and intra-arterial intervention is more likely to produce a better outcome for patients than intravenous r-tPA alone, and its important that the trial reflect current standards of care among our investigators. Thus, The Penumbra System is a welcome addition to existing interventional options in the IV-IA arm of the trial, said Joseph Broderick, MD - Professor; Chairman, Department of Neurology, University of Cincinnati; Director, Greater Cincinnati/Northern Kentucky Stroke Team; and Primary Neurologist Investigator of the IMS III Trial.

It has always been the intention of the IMS III Trial for all devices that have FDA clearance to treat cerebral occlusions in acute stroke patients be invited to join the trial. In addition, neurointerventionalists want to have all major options at their disposal to treat this disease. For these reasons, were pleased to have The Penumbra System as part of the armamentarium available to investigators in IMS III, said Thomas Tomsick, MD - Professor; Director, Neuroradiology, University of Cincinnati and University Hospital; and Primary Interventional Investigator of the IMS III Trial.

The IMS III trial is the most important scientific effort currently underway to define appropriate treatment methodology for ischemic stroke patients in the zero to three hour time window. We are honored to be a part of it, said Adam Elsesser, CEO, Penumbra, Inc.

The Penumbra System is a package of tools used by neurointerventional specialists to remove occlusions from the large vessels of the brain that are causing an acute ischemic stroke. It works on the proximal surface of the occlusion to debulk and gently aspirate clots out of the vessel.

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. Penumbras global headquarters is located in Alameda, California with sales operations in the United States, Europe and Asia.

ABOUT The IMS III Trial

The purpose of this study is to compare two different treatment approaches combined intravenous and intra-arterial (IA) therapy and standard intravenous (IV) r-tPA to restoring blood flow to the brain. The primary goal is to determine if individuals with ischemic stroke treated using a combined IV/IA approach to recanalization started within 3 hours of onset are more likely to have a better outcome than individuals treated with standard IV r-tPA alone. For more information, see: www.clinicaltrials.gov/ct2/show/NCT00359424


Source: Penumbra

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