FDA Approves Medtronic’s Pipeline Flex Embolization Device

The FDA approved Medtronic’s Pipeline Flex, a flow diversion device used to treat large and giant wide-necked brain aneurysms. According to the company, the device can treat brain aneurysms that are not amenable to treatment with surgical clipping and are attached to parent vessels measuring between 2.5 and 5.0 mm in diameter. "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.

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," said Dr. Ricardo Hanel, Neurosurgeon, Director of stroke and Cerebrovascular Center at Baptist Health in Jacksonville, Florida.

Designed to divert blood flow away from an aneurysm, the 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.

"This 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. We are excited to bring new value to our medical community," said Brett Wall, president, Neurovascular, Medtronic.

Source-Medindia