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.
"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.