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 REVIVE™ SE," said Dr. Bendszus, who is an investigator for RIVER I (Reperfuse Ischemic Vessels with Endovascular Recanalization), a recently initiated, single-arm study in Germany that will include patient screening with MRI before treatment with REVIVE™ SE.

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.[i],[ii]

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.

"The REVIVE™ SE represents Codman's first product entry into ischemic stroke, due in large part to our recent acquisition of Micrus Endovascular," said Karen Prange, General Manager and Vice President, Codman Neurovascular. "This is the beginning of a long term commitment to bring forward more innovations that advance the treatment of stroke and improve patient care, outcomes and access to treatment."

Over the last several months, Codman, through its Codman Neurovascular business unit, introduced the NEUROSCOUT™ Steerable Guidewire and the XTRASOFT™ ORBIT GALAXY™ Coil globally, as well as the ENTERPRISE™ Vascular Reconstruction Device and Delivery System in Japan for the treatment of wide-necked intracranial aneurysms.

In late 2010, Johnson & Johnson acquired Micrus Endovascular, a global developer and manufacturer of minimally invasive devices for hemorrhagic and ischemic stroke, which now operates under Codman Neurovascular.

*Paid consultant to Codman.

[i] World Health Organization. "The World Health Report." 2007. Available here.

[ii] American Heart Association. "International Cardiovascular Disease Statistics." 2007. Available here.

Codman & Shurtleff, Inc.

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