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The Product
The Micrus ACT™ MicroCoil Delivery System was introduced
to the European market in September 2000 at the European Society of Neuroradiologists
(ESNR) meeting in Oslo, Norway. This is the first product to come to market
from the extensive patent portfolio of Micrus Endovascular.
Market Clearance and Quality Systems Compliance of The ACT MicroCoil System™
CE Mark - May 2000
Food & Drug Administration (FDA) 510(k) clearance in the United States
- October 2000
US FDA audit - December 2000
Micrus Endovascular operations and quality system are registered to BS EN
ISO 9001:1994, EN 46001 and the European Medical Device Directives (93/42/EEC,
Annex II)
ACT™ MicroCoil Delivery System
The Company is marketing this state-of-the-art occlusive
aneurysm MicroCoil under the brand ACT™ MicroCoil Delivery System. The
MicroCoils are placed and deployed within the aneurysm by means of the proprietary
low temperature Resistive Heating (RH) delivery system. The MicroCoil element
of the system is available in two configurations (spherical or helical) and
a range of sizes to enable treatment of a range of aneurysm sizes. The MicroSphere™
spherical coil is used to frame the aneurysm. Depending on the size of the
aneurysm, one or more MicroSpheres™ can be deployed for the purpose of
framing. Subsequent HeliPaq™ helical coils are then used to fill the
aneurysm.
Unique Features of Micrus MicroCoil Delivery System
The Micrus MicroCoil System is differentiated from other
systems by a unique "frame and fill" technique and by a rapid detachment
mechanism. The aneurysm is first framed by deploying a spherically shaped
MicroCoil that assumes an anatomically compliant frame within the aneurysm's
fragile perimeter. In aneurysms with greater than 4 mm diameter, a second
spherical coil may be deployed to strengthen the frame. The frame is then
rapidly filled with helical MicroCoils until the aneurysm is completely occluded
from the cerebral circulation.
Each MicroCoil detachment is accomplished with the push of a button. Detachment
consistently occurs in 5 seconds or less making the ACT™ MicroCoil System
the newest generation of aneurysm coils.
