FDA approves Pipeline Flex embolisation device


Medtronic plc has announced that it has received US Food and Drug Administration (FDA) approval for its Pipeline Flex embolisation device. Available through a limited US launch in the coming weeks, Medtronic’s latest-generation flow diversion device represents an unrivalled advancement in large and giant brain aneurysm treatment.

“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,” says Ricardo Hanel, neurosurgeon, director of the Stroke and Cerebrovascular Center at Baptist Health in Jacksonville, USA. “With thousands of patients successfully treated with Pipeline embolisation device, the Pipeline Flex’s innovative delivery system will result in further advancing endovascular treatment and care.”

Designed to divert blood flow away from an aneurysm, the Pipeline Flex embolisation device features a braided cylindrical mesh tube that is implanted across the base or neck of the aneurysm. The device cuts off blood flow to the aneurysm, reconstructing the diseased section of the parent vessel.

“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 improved accuracy and control when performing these advanced procedures inside the brain,” says Brett Wall, president, Neurovascular, Medtronic. “We are excited to bring new value to our medical community and patients.”

In the United States, the Pipeline Flex device is intended for use for the endovascular treatment of complex intracranial aneurysms that are not amenable to treatment with surgical clipping and are attached to parent vessels measuring between 2.5 and 5mm in diameter. An estimated 500,000 people throughout the world die each year caused due to ruptured brain aneurysms, and half the victims are younger than 50 years of age.

The first-generation Pipeline embolisation device has been used to treat patients in the United States since it was approved by the FDA in 2011. This product is part of the Neurovascular portfolio in Medtronic’s Restorative Therapies Group.