CE Mark In Europe For CORDIS ENTERPRISE™ Vascular Reconstruction Device And Delivery System To Assist In The Treatment Of Intracranial Aneurysms

Main Category: Stroke
Also Included In: Clinical Trials / Drug Trials;  Medical Devices / Diagnostics
Article Date: 23 Dec 2006 - 0:00 PDT

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Cordis Neurovascular, Inc., announced today that the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System received the CE Mark in Europe for use with occlusive devices in the treatment of intracranial aneurysms.

An intracranial aneurysm is a weak spot in the wall of a blood vessel in the brain that balloons out, forming a thin walled bubble or sac. Hemorrhagic stroke occurs when a cerebral aneurysm bursts and bleeds into brain tissue. Stroke is the third leading cause of death throughout Europe and is the most common cause of adult physical disability. In addition, stroke imposes a significant burden on society and on healthcare budgets, accounting for three-four percent of the total health care costs in Western European countries.

The CORDIS ENTERPRISE™ Vascular Reconstruction Device is approved in Europe to assist in coiling procedures. A coiling procedure is an endovascular neurointervention in which coils (implantable medical devices made of long strands of very thin, coiled wire) are used to fill aneurysms to facilitate clot formation and occlude blood flow to reduce the risk of aneurysm rupture. The CORDIS ENTERPRISE™ VRD acts as a scaffold to hold the coils in place inside the aneurysm.

Dr. Martin Bendzus comments, "Patients that could hardly be treated before will be treated much more safely via an endovascular procedure with CORDIS ENTERPRISE™."

The CORDIS ENTERPRISE™ VRD is an important advancement in neuro-stent technology. Pre-loaded onto a delivery system composed of an introducer and delivery wire for a simple system configuration, the CORDIS ENTERPRISE™ VRD enables physicians to recapture the stent and three radiopaque zones facilitate placement and visibility. The unique and flexible closed cell design provides conformability and true vessel reconstruction at the neck of the aneurysm and an advanced scaffold for outstanding coil mass support.

The clinical outcomes from the CORDIS ENTERPRISE™ Vascular Reconstruction Device Study, involving patients in Europe and the U.S., establish a new standard for clinical evidence in the treatment of intracranial aneurysms. Data from the independently evaluated clinical study suggest that the CORDIS ENTERPRISE™ VRD is a promising assist device for the treatment of aneurysms.

Cordis Neurovascular, Inc.

Cordis Neurovascular, Inc., develops, manufactures and markets medical devices for the neurovascular applications, particularly cerebral embolization procedures. Marketed products include the TRUFILL DCS ORBIT™ Detachable Coil System, the TRUFILL® n-BCA Liquid Embolic System and a variety of complementary access products including the ENVOY® Guiding Catheter, PROWLER® SELECT™ Microcatheters and the HYPERTRANSIT™ Microcatheter.

Cordis Neurovascular, Inc.
http://www.cordis.com/