FDA approves Medtronic’s PipelineFlex embolization device

5 February 2015 (Last Updated February 5th, 2015 18:30)

The US Food and Drug Administration (FDA) has granted approval for Medtronic's Pipeline Flex embolization device, developed for large and giant brain aneurysm treatment.

The US Food and Drug Administration (FDA) has granted approval for Medtronic's Pipeline Flex embolization device, developed for large and giant brain aneurysm treatment.

Available through a limited US launch in the next few weeks, the company's minimally-invasive flow diversion device for unruptured brain aneurysms is designed for more exact and controlled placement.

Baptist Health director of stroke and Cerebrovascular Center Dr Ricardo Hanel said: "Flow diversion has been a major breakthrough therapy for large or giant wide-necked brain aneurysms that are complex and have considerably higher risk of rupture and higher rates of complication with conventional treatment.

"The device is capable of diverting blood flow away from an aneurysm, and features a braided cylindrical mesh tube that is implanted across the base or neck of the aneurysm."

"With thousands of patients successfully treated with Pipeline embolization device, the Pipeline Flex's innovative delivery system will result in further advancing endovascular treatment and care."

The device is capable of diverting blood flow away from an aneurysm, and features a braided cylindrical mesh tube that is implanted across the base or neck of the aneurysm.

The Pipeline Flex embolization device cuts off blood flow to the aneurysm and reconstructs the diseased section of the parent vessel.

Medtronic president of Neurovascular Brett Wall said: "The Pipeline Flex embolization device is the next advancement in flow diversion, combining our clinically-proven braid design with a new delivery system designed to offer improved accuracy and control when performing these advanced procedures inside the brain."

The device is indicated in the US for 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 5mm in diameter.