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Registry Data Shows 90% Of Patients Independent, Free Of Significant Disabilities After Treatment With Codman System For Wide-necked Aneurysms
Date:9/18/2012

axmin Laxminarain, Worldwide President of Codman & Shurtleff, Inc. "We are pleased that this registry data is consistent with previous short and mid-term studies on the device."

Codman received Humanitarian Device Exemption (HDE) approval for the CODMAN ENTERPRISE VRD, a self-expanding stent and delivery system, from the U.S. Food and Drug Administration (FDA) in 2007 and CE Mark approval in 2006. HDE approval is granted for Humanitarian Use Devices (HUD) that are intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in less than 4,000 individuals in the United States per year and for which no comparable device is available. HDE approval is based on safety and probable benefit; HDEs are exempt from the requirement to provide a reasonable assurance of effectiveness. 

Neurointerventional centers participating in the registry include: University at Buffalo, University of Florida, University of Cincinnati, West Virginia University, University of Puerto Rico, Albany Medical Center Hospital, Capital Health System, University of Texas Southwestern, and Mayo Clinic.

About Codman & Shurtleff, Inc.
Codman is a global neurosurgery, neurovascular and neuromodulation company that offers a broad portfolio of devices for drug delivery, hydrocephalus management, neuro intensive care and cranial surgery as well as aneurysm coils, vascular reconstruction devices and other technologies used in the endovascular treatment of cerebral aneurysms and stroke. Codman is part of DePuy Synthes Companies of Johnson & Johnson. Visit www.codman.com and www.depuysynthes.com for more information.

*HUMANITARIAN DEVICE (USA ONLY):The CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System is authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial,
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SOURCE Codman & Shurtleff, Inc.
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