MICRUS MICROCOIL DELIVERY SYSTEM DESCRIPTION

The Micrus MicroCoil System consists of an embolic coil (of various shapes and dimensions) attached to a Device Positioning Unit. It is a single use, sterile device with the embolic coil being a permanent implant and the Device Positioning Unit being an intraoperative guide wire that is used to guide the coil into the mouth of the aneurysm. The number of coils used to treat a patient is dependent upon the size of the aneurysm.

The Micrus MicroCoil System is connected to a nonsterile Detachment Control Box via a sterile Connecting Cable. A single Connecting Cable is used for each patient.

The Micrus MicroCoil System is differentiated from predicate systems by a unique "frame and fill" technique and by a rapid detachment mechanism.

The aneurysm is first framed by deploying a spherically shaped MicruSphere coil that assumes an anatomically compliant frame within the aneurysm's fragile perimeter. In aneurysms with greater than 4 mm diameters, a second MicruSphere coil may be deployed to strengthen the frame. This frame is then rapidly filled with helically shaped MicroCoils until the aneurysm is completely occluded.

Each MicroCoil's detachment is accomplished with the push of a button. Detachment consistently occurs in 5 seconds or less.