Stable

Variable loop design allows the coil to brace against aneurysm walls and provide stable framing across the aneurysm neck.

Efficient

Available in longer lengths to increase number of loops during framing and provide more volumetric filling per coil.

Controlled Delivery and Reliable Detachment

Paired with V-Trak delivery system with excellent performance from coil introduction to coil delivery and detachment.

Headway™ Duo 156 Microcatheter, Headway™ 17 Microcatheter, Headway™ 21 Microcatheter.

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.

MR Conditional

The FRED (Flow Re-direction Endoluminal Device) and LVIS (Low-profile Visualized Intraluminal Support Device) are MR Conditional. Non-clinical testing demonstrated that these devices are MR Conditional. A patient with this device can be scanned safely, immediately after placement under the following conditions:

- Static magnetic field of 1.5-Tesla and 3-Tesla, only

- Maximum spatial gradient magnetic field of 2,500-Gauss/cm (extrapolated) or less

- 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)

- Normal Operating Mode of operation for the MR system

MRI-Related Heating

In non-clinical testing , the FRED (Flow Re-direction Endoluminal Device) and LVIS (Low-profile Visualized Intraluminal Support Device) produced the following temperature rises during MRI performed for 15-min of scanning (i.e., per pulse sequence) in 1.5-Tesla/64-MHz (Magnetom, Siemens Medical Solutions, Malvern, PA. Software Numaris/4, Version Syngo MR 2002B DHHS Active-shielded, horizontal field scanner) and 3-Tesla (3-Tesla/128-MHz, Excite, HDx, Software 14X.M5, General Electric Healthcare, Milwaukee, WI) MR systems:

MR system reported, whole body averaged SAR

1.5-Tesla

2.9-W/kg          

3-Tesla

2.9-W/kg

Calorimetry measured values, whole body averaged SAR

1.5-Tesla

2.1-W/kg          

3-Tesla

2.7-W/kg

Highest temperature change

1.5-Tesla

2.8˚C        

3-Tesla

3.6˚C

Artifact Information

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the FRED or LVIS device. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary. The maximum artifact size (i.e., as seen on the gradient echo pulse sequence) extends approximately 4-mm relative to the size and shape of this implant. The lumen of this device can be visualized using the MRI techniques applied for the artifacts tests.

Pulse Sequence    T1-SE         T1-SE        GRE        GRE 

Signal Void Size     462-mm2      41-mm2       743-mm2     72-mm2

Plane Orientation    Parallel       Perpendicular   Parallel      Perpendicular