German Doctors Use New Self-Expanding Clot Removal Device for Ischemic Stroke
May 23, 2011 - Doctors in Germany are among the first to treat ischemic stroke patients outside the United States with the Revive SE, a new self-expanding blood clot retrieval and removal device designed to remove blood clots and restore blood flow to the brain in patients having a stroke.
Codman & Shurtleff Inc., a global neuroscience and neurovascular company, received CE mark authorization for the Revive SE in February 2011. CE mark approval means that the product has been deemed safe for use in occlusions or blockages in blood vessels or grafts and can now be marketed for this indication in all Member States of the European Union (EU), European Economic Area and Switzerland. The device is not approved for distribution in the United States.
The Revive SE provides physicians with a new option for treating ischemic stroke, which occurs when not enough blood gets to the brain and causes symptoms including sudden numbness or weakness of the face, arms or legs, confusion, vision loss, dizziness or severe headache. The device is a self-expanding nitinol basket that provides a temporary bypass across the occlusion in the brain. It can also be used for the non-surgical removal of emboli and thrombi, and be used with aspiration.
According to the World Health Organization (WHO), ischemic strokes account for about 90 percent of the 15 million strokes that occur worldwide each year. Hemorrhagic strokes occur when an artery in the brain bursts. Europe averages approximately 650,000 stroke deaths each year. Stroke is the leading cause of death after heart disease and cancer and WHO calls neurological disorders, which affect about 1.7 billion people, one of the greatest threats to public health.
The Revive SE is inserted with a microcatheter across the occlusion or beyond its distal edge, at which point it is deployed and expands into the vessel. It can be redeployed multiple times based on the severity of the clot. The device features a closed distal end to help prevent portions of the clot from moving further upstream within the vessel. The basket engages the clot for effective removal, is reconstrainable to ease retrieval, and is designed for optimal centering within the vessel lumen during deployment and retrieval.