Device Dossier
WEB Aneurysm Embolization System - Neurovascular embolization coil
Device Dossier for WEB Aneurysm Embolization System - Neurovascular embolization coil (Neurovascular embolization coil, Class III, sponsor Life…
- GMDN category: Neurovascular embolization coil
Intended purpose
The WEB Aneurysm Embolization System is intended for the endovascular embolization of ruptured and unruptured intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae(AVF). The WEB Aneurysm Embolization System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation.The device should only be used by physicians who have undergone appropriate training.
Functional description
The WEB Aneurysm Embolization System consists of an implantable embolization device attached to a delivery device. The device is manufactured from nitinol wires in a braided, self-expanding mesh configuration available in a broad range of diameters and lengths to meet the specific needs of the patient. The device is separated from the delivery device by the use of a separate battery-powered detachment control device. The device is supplied sterile and is single use.