Cordis Receives FDA Humanitarian Device Exemption for Vessel Reconstruction System

The FDA has cleared the Cordis Enterprise Vascular Reconstruction Device and Delivery System under the Humanitarian Device Exemption.
It is used with embolic coils for the treatment of intracranial aneurysms and consists of a self-expanding stent and a delivery system. The stent, which is a self-expanding, metal (nitinol) mesh in the shape of a tube, serves as a scaffold for embolic coils to prevent herniation of the coils into the parent vessel.
The delivery system is composed of an introducer and delivery wire and is used to deliver the stent to the treatment site in the neurovasculature.
The Cordis Enterprise is intended for use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms. The stent serves as a scaffold for embolic coils to prevent herniation of the coils into the parent vessel.