RAYNHAM, Mass., May 11, 2011 /PRNewswire/ -- 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 Conformite Europeenne (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.
"This device is an important new option because it may provide advantages over currently available treatments," said Martin Bendszus*, MD, 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 recanalization, enhanced efficacy in treating larger vessel occlusions and thus have an improved clinical outcome."
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.
"Every stroke is different, and we are now exploring the use of imaging to determine which patients may benefit most from treatment with RE