Innovative Stroke Device Receives FDA Clearance

The Penumbra Stroke System, a new device to remove blood clots in the brains of patients with acute ischemic stroke, has received clearance from FDA.

Rush University Medical Center was one of the first centers in the U.S. to study the safety and effectiveness of the Penumbra Stroke System.

The Penumbra Stroke System uses aspiration and catheterization techniques to rapidly restore blood flow in the brain and limit damage caused by stroke. Unlike clot dissolving drugs which must be administered within a short three-hour treatment window, the Penumbra system can be used within eight hours of symptom onset.

"The Penumbra System brings a new concept to the treatment of stroke which we did not have before. It adds significantly to our arsenal of tools to treat acute ischemic stroke," said Dr. Demetrius Lopes, an endovascular neurosurgeon and assistant professor of neurosurgery at Rush.

Penumbra is delivered into the brain using a catheter inserted through a small puncture in the groin. Using x-ray guidance, the device is maneuvered through the blood vessels of the body to the site of the clot in the brain. A separator is advanced and retracted through the catheter to dislodge the clot and a suction device grabs hold of it for removal.

The system was designed taking into account the many variables and complications that have prevented other devices from working well. Compared with the first generation of mechanical clot removing devices which use a corkscrew-shaped coil to snag the blood clot, the Penumbra uses suction to grab the blood clot and remove it from the body.

"Instead of piercing the clot to retrieve it, with Penumbra we attack it with suction. We are able to remove rigid clots that we could not remove with other mechanical devices," said Lopes.

Clinical results from the pivotal trial of the Penumbra System will be presented at the 2008 American Stroke Association International Stroke Conference in New Orleans on Friday, February 22. Based upon the American Stroke Association's requirements, the clinical data is embargoed from public disclosure prior to presentation at the International Stroke Conference.

"We are extremely pleased that the Penumbra System will be available commercially in the United States. Ischemic stroke is a complex problem that requires a variety of different approaches," said Lopes. "Clots come in different shapes and sizes and are made of different materials. It is important to have a variety of tools available to handle all the different situations we face."

In the pivotal trial, in addition to the aspiration devices, the system included a clot-grabbing device that was designed to be used if the aspiration devices were not successful. Based upon the results of the trial with the aspiration devices, and due to the small number of cases in which the clot-grabbing device was necessary, Penumbra, in consultation with the FDA, decided to exclude the clot-grabbing device from its final submission.

Ischemic stroke is the third-leading cause of death in the United States and the leading cause of disability. Each year in the U.S. alone, over 700,000 people suffer from a stroke. Clinical signs consistent with acute ischemic stroke include sudden numbness or weakness in the face or extremities, sudden confusion, trouble speaking or understanding speech, sudden trouble walking, dizziness, or loss of balance.