Penumbra System Added to IMS III Stroke Trial Protocol

October 21, 2009—Penumbra, Inc. (Alameda, CA) announced that the Penumbra system has been added as a therapeutic option in the combined intravenous and intra-arterial (IV/IA) therapy arm of the IMS III (International Management of Stroke 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. The Penumbra system is an aspiration-based thrombectomy device that works on the proximal surface for interventional debulking and removal of cerebral clots in acute stroke patients, the company stated.

The purpose of this study is to compare two different treatment approaches—combined IV/IA therapy and standard intravenous recombinant tissue plasminogen activator (r-tPA)—to restore blood flow to the brain. The primary goal is to determine if individuals with ischemic stroke who were 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.

"It is important that the trial reflect current standards of care among our investigators," commented Joseph Broderick, MD, who is the primary neurologist investigator of the IMS III trial. "Thus the Penumbra system is a welcome addition to existing interventional options in the IV-IA arm of the trial."

Thomas Tomsick, MD, who is the study's principal interventional investigator, added, "It has always been the intention of the IMS III trial for all devices that have US Food and Drug Administration clearance to treat cerebral occlusions in acute stroke patients be invited to join the trial. In addition, neurointerventionists want to have all major options at their disposal to treat this disease. For these reasons, we are pleased to have the Penumbra system as part of the armamentarium available to investigators in IMS III."