Medtronic plc has received U.S. Food and Drug Administration approval for its Pipeline Flex embolization device. Available through a limited U.S. launch, Medtronic’s latest-generation flow diversion device represents an 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,” said Dr. Ricardo Hanel, Neurosurgeon, director of stroke and cerebrovascular center at Baptist Health in Jacksonville, Florida. “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.”
Designed to divert blood flow away from an aneurysm, the Pipeline Flex embolization 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.
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 5.0 mm in diameter.
The first-generation Pipeline embolization 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. •