Ireland-based Covidien has introduced its Pipeline Flex embolisation device in Europe, intended for the endovascular embolisation of cerebral aneurysms.
The launch further strengthens the company’s broad line of neurovascular products for treatment of unruptured brain aneurysms.
The minimally invasive device, which secured CE Mark approval earlier this year, has been designed to divert blood flow away from an aneurysm.
Pipeline Flex includes a braided cylindrical mesh tube that is implanted across the base or neck of the aneurysm and it cuts off blood flow to the aneurysm, reconstructing the diseased section of the parent vessel.
Covidien Neurovascular president Brett Wall said: "The Pipeline Flex embolisation device is the next advancement in flow diversion, combining our clinically-proven braid design with a new delivery system designed to offer even more accuracy and control when performing these advanced procedures inside the brain.
"Covidien is dedicated to seeking customer feedback and advancing product design to meet their needs."
The company has designed the repositionable device to provide even more accuracy and controlled placement, while it features an instant braid release system that makes it even easier to place.
Approximately 500,000 deaths are caused by brain aneurysms every year, with half of victims younger than 50 years of age, according to The Brain Aneurysm Foundation.
Since 2009, the first-generation Pipeline embolisation device is being used for treatment of patients in Europe.
The device has been the only flow diversion device commercially available in the US since it was approved by the US Food and Drug Administration (FDA) in April 2011.
Currently, the Pipeline Flex device is not approved for use in the US.
Image: Covidien’s new Pipeline Flex device is intended for the endovascular embolisation of cerebral aneurysms in Europe. Photo: courtesy of Business Wire/ Covidien plc.