Penumbra Inc.'s ischemic stroke device platform, the Penumbra System®
, is designed to revascularize or open up a blood vessel that is blocked by a blood clot. The pathology of brain tissue starved of oxygen by a blocked blood vessel is a gradual progression from reversible ischemia to irreversible infarction (cell death).
The penumbra, a rim of ischemic but still viable tissue that surrounds a central core of infarction, has consistently been shown in animal models to be salvageable if blood flow can be restored within a certain time window. Data from human studies with surrogate measurements of cell viability tended to support this hypothesis. Thus, current treatment strategy for ischemic stroke is based on an urgent restoration of blood flow to the ischemic penumbra within a time window to prevent the permanent loss of brain cells, leading to improved outcome for the patient.
Currently there is only one FDA-approved treatment for an acute ischemic stroke: intravenous (IV) delivery of Tissue Plasminogen Activator (t-PA) (Activase), which is a thrombolytic agent. The agent is designed to dissolve the blood clot that is blocking blood flow to the brain. IV t-PA is currently limited in use since it must be used within a 3-hour window from the onset of the stroke and it appears to carry an increased risk of bleeding.
An option beyond the 3-hour window is a thromboembolectomy device. Penumbra's device has been designed taking into account many of the variables and complications that have prevented other devices from working well in this area.
The Penumbra System
is FDA cleared and CE–marked. It is available for sale in the United States, Europe, Japan, and many other parts of the world.