Title

Aneurysms: vascular reconstruction device (VRD)and delivery system (DS)(humanitarian device)

Publication/Presentation Date

2013

Abstract

Description HDE Device - Self-expanding stent system for use with embolic coils for treatment of wide-neck, intracranial, saccular or fusiform aneurysms. Use of the device is hoped to reduce risk of subarachnoid hemorrhage by increased ability to treat aneurysms. Eligibility Patients with angiographically documented wide-neck, intracranial, saccular or fusiform aneurysms, either ruptured or unruptured, who are deemed by the attending neurointerventionalist to be acceptable candidates for endovascular embolization. There are no age or gender restrictions. Purpose The CORDIS ENTERPRISE (TM)Vascular Reconstruction Device and Delivery System is authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms arising from a parent vessel with a diameter of > 3 mm and < 4 mm. Wide-neck is defined as having a neck width 4 mm or a dome-to-neck ration < 2. The effectiveness of this device for this use has not been demonstrated.

Disciplines

Cardiology | Medicine and Health Sciences

Document Type

Research

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