Indications for Use
The MicroPlex Coil System (MCS) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS 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 and for arterial and venous embolizations in the peripheral vasculature.
The device should only be used by physicians who have undergone pre-clinical training in all aspects of MCS procedures as prescribed by MicroVention.
Non-clinical testing and MRI simulations were performed to evaluate the entire family (i.e., available diameters and lengths) of the MicroPlex Coil System (MCS). Non-clinical testing demonstrated that the entire family of these embolization coils (see table below) is MR Conditional. A patient with an implant from this family can be scanned safely in an MR system under the following conditions:
- Static magnetic field of 1.5-Tesla and 3-Tesla, only
- Maximum spatial gradient magnetic field of 4,000-gauss/cm (40-T/m)
-Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode
Under the scan conditions defined, the MicroPlex Coil System (MCS) is expected to produce a maximum temperature rise of 2.3˚C after 15-minutes of continuous scanning (i.e., per pulse sequence).
In non-clinical testing, the image artifact caused by the MicroPlex Coil System (MCS), Cosmos 18 extends approximately 5-mm from this device when imaged with a gradient echo pulse sequence and a 3-Tesla MR system.
