Doctors in Germany are among the first to treat ischaemic stroke patients outside the United States with the Revive SE (Codman and Shurtleff), a new self-expanding blood clot retrieval and removal device.
“This device is an important new option because it may provide advantages over currently available treatments,” said Martin Bendszus, Department of Neuroradiology, University of Heidelberg in Germany, who has successfully treated more than 25 patients with the Revive SE. “Patients treated with neurothrombectomy devices such as Revive SE may achieve rapid recanalisation, enhanced efficacy in treating larger vessel occlusions and thus have an improved clinical outcome.”
Codman & Shurtleff, received CE mark authorisation for the Revive SE in February 2011.
This 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.
“Every stroke is different, and we are now exploring the use of imaging to determine which patients may benefit most from treatment with Revive SE,” said Bendszus, who is an investigator for RIVER I (Reperfuse ischaemic vessels with endovascular recanalisation), a recently initiated, single-arm study in Germany that will include patient screening with MRI before treatment with Revive SE.
The self-expanding clot removal device 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.
According to the World Health Organisation, ischaemic strokes account for about 90% of the 15 million strokes that occur worldwide each year. Europe averages approximately 650,000 stroke deaths each year. Stroke is the leading cause of death after heart disease and cancer and the World Health Organisation calls neurological disorders, which affect about 1.7 billion people, one of the greatest threats to public health.
“The Revive SE represents Codman’s first product entry into ischaemic stroke, due in large part to our recent acquisition of Micrus Endovascular,” said Karen Prange, general manager and vice president, Codman Neurovascular.”
The device is not approved for distribution in the United States.