Irish medical technology firm Medtronic has obtained approval from the US Food and Drug Administration (FDA) for its Pipeline Flex embolization device, designed for large and giant brain aneurysm treatment.
In the US, the device is aimed at the endovascular treatment of complex intracranial aneurysms, which are not amenable to treat with surgical clipping and are attached to parent vessels measuring between 2.5mm and 5.0mm in diameter.
Medtronic neurovascular president Brett Wall said: "We are excited to bring new value to our medical community and patients.
"The Pipeline Flex embolization device is the next advancement in flow diversion, combining our clinically-proven braid design2 with a new delivery system designed to offer improved accuracy and control when performing these advanced procedures inside the brain.
Developed to divert blood flow away from an aneurysm, the device features a braided cylindrical mesh tube, which is implanted across the base or neck of the aneurysm.
The device will amputate the blood flow to the aneurysm and reconstruct the diseased section of the parent vessel.
Medtronic noted that the first-generation Pipeline embolization device has been used to treat patients in the US since it was approved by the FDA in 2011.