Medtronic plc, has received U.S. FDA approval for the Pipeline™ Flex embolization device, recently absorbed into its product catalogue with the acquisition of Covidien.
Background
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. Launched last year in Europe, Pipeline Flex is a minimally-invasive flow diversion device for unruptured brain aneurysms. It will now form part of the Neurovascular portfolio in Medtronic`s Restorative Therapies Group and will be made available through a limited U.S. launch in the coming weeks
Designed to divert blood flow away from the aneurysm, the device features a braided cylindrical mesh tube that is implanted across its base or neck. The device cuts off blood flow to the aneurysm, effectively 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.
Physician comments
“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.”
Company comments
“The Pipeline Flex embolization 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,” said Brett Wall, president, Neurovascular, Medtronic. “We are excited to bring new value to our medical community and patients.”
Source: Medtronic plc
published: February 5, 2015 in: Approval/Clearance, Medtronic, Neuro