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New Humanitarian Device Approval

NEUROLINK® System - H010004

FDA approved this device under the Humanitarian Device Exemption (HDE) program http://www.fda.gov/cdrh/ode/hdeinfo.html. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.

 Neurolink System

Product Name: NEUROLINK® System
Manufacturer: Guidant Corporation
Address: 1525 O’Brien Drive, Menlo Park, California 94025
Approval Date: August 9, 2002
Approval Letter: http://www.fda.gov/cdrh/pdf/H010004a.pdf

What is it? The NEUROLINK® System, which is used to treat certain stroke patients, consists of the NEUROLINK® Stent & Delivery Catheter and the NEUROLINK® Balloon Dilatation Catheter. The NEUROLINK® Stent & Delivery Catheter consists of an expandable stainless steel device (a stent) that provides structural support for a blood vessel, helping to keep it open. The stent is mounted on a thin tube (a catheter) with a balloon tip.

How does it work? The delivery catheter provides a means for carrying the NEUROLINK® Stent through the circulatory system into the blood vessels within the skull that deliver blood to the brain and need to be widened. The delivery catheter places and expands the stent to a specific diameter at a specified pressure. Once the device is positioned properly, the dilatation catheter enlarges the inner diameter of the affected arteries.

When is it used? The NEUROLINK® System is used for the treatment of patients with recurrent intracranial stroke due to an accumulation of fatty deposits in their intracranial blood vessels (atherosclerotic disease) who did not respond to medical therapy. This system is used for intracranial vessels ranging from 2.5 to 4.5 mm in diameter, with 50% or more narrowing in the blood vessel. For a drawing of blockage in the brain arteries go to: http://www.nlm.nih.gov/medlineplus/ency/imagepages/17133.htm

What will it accomplish? It may help maintain an adequate diameter in the vessel and allow adequate blood flow to the brain.

When should it not be used? It should not be used in patients who have:

Additional information:
Summary of Safety and Probable Benefit and labeling is available at: http://www.fda.gov/cdrh/ode/H010004sum.html

Other:

National Institutes of Health Information

Updated 1/15/2003

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